SARS-CoV-2 InfectionPhase 3NCT04487574
A Study to Assess the Efficacy and Safety of XC221 in Patients With COVID-19
A Phase 3 study testing XC221 in people with SARS-CoV-2 Infection, run by RSV Therapeutics LLC at 5 sites in Russia.
Trial summary
The innovative drug XC221 100 mg tablet is designed for the treatment of COVID-19 (SARS-CoV-2 infection). A multicenter, adaptive, randomized, double-blind, placebo-controlled Phase III clinical study is aimed to assess the efficacy and safety of XC221 100 mg tablet, in COVID-19 patients during a 14-day treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- XC221
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 5 sitesRussia
- Study dates
- 25 Jul 2020to 29 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form.
- Patients of both sexes aged 18 to 75 years inclusive.
- Diagnosed COVID-19 based on:
- positive laboratory tests confirming the SARS-CoV-2 presence, performed no earlier than 14 days before hospitalization. It is allowed to determine the SARS-CoV-2 by the PCR or by another method according to the MoH Temporary Guidelines; and / or
- bilateral alterations in lungs, typical for COVID-19, according to CT scan of the chest.
- Patients with moderate or severe form of disease (t > 38.0°C; respiratory rate (RR) >22 / min; Sp02 <95%) not requiring non-invasive / invasive ventilation and / or high-flow oxygenation (HFNT), and / or extracorporeal membrane oxygenation (EMO) at the time of screening and randomization (based on the MoH Temporary Guidelines).
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- Patients requiring oxygen therapy (oxygenation through a nasal cannula, a simple facemask or other similar oxygen delivery device) with a category "4" according to the WHO scale.
- Time from hospitalization to the first drug administration should not exceed 48 hours. This item is to be assessed only when re-evaluating the inclusion / exclusion criteria at the Randomization visit and treatment initiation.
- Disease duration is no more than 7 full days since the moment of appearing one or more of the symptoms below until the first dose of the drug administration:
- temperature increase;
- dry cough or cough with little phlegm;
- shortness of breath;
- myalgia;
- fatigue;
- feeling of congestion in the chest;
- reduced sense of smell and / or taste.
- For women only: negative pregnancy test result. Pregnancy testing is not required for women of not childbearing potential (WONCBP): women who are in menopause (defined as an absence of menstruation for at least 2 years or more), or women who undergone surgical sterilization (hysterectomy, bilateral oophorectomy, tubal ligation), or women with a clinical diagnosis of "infertility". The presence of surgical sterilization and infertility should be confirmed by patient's claim or by relevant document confirming this condition.
- Consent to use reliable method of contraception throughout the study period.
- Patients who are able to understand and comply with treatment and procedures during the study.
Who cannot join
- Known or suspected hypersensitivity to the active substance or to excipients of the drug XC221 or placebo
- Known or suspected hypersensitivity to standard therapy drugs specified in The MoH Temporary Guidelines.
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
- Presence or suspicion of oncological diseases by the day of criteria assessment or in medical history (within the last 2 years).
- Presence of autoimmune diseases by the day of criteria assessment or in medical history.
- Neutropenia (0.5 * 10^9 /l).
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- Exceeding the upper limit of normal for ALT and AST by 5 times or more.
- Thrombocytopenia 50000 / mm^3.
- Pregnancy.
- Lactation.
- Presence of serious lung diseases, including, but not limited to the following diseases: moderate and severe bronchial asthma, severe and extremely severe COPD, interstitial lung disease, pulmonary hypertension, pulmonary fibrosis, surgical interventions on the lungs, tuberculosis (including suspicion of tuberculosis based on the results of CT examination at screening).
- Patients with type 1 diabetes mellitus and / or decompensated type 2 diabetes mellitus.
- Heart failure, NYHA functional class III - IV.
- Chronic liver failure stage II (decompensated) and higher.
- The need of renal replacement therapy at the time of inclusion of the patient.
- Organ transplantation in medical history.
- Medical history of epilepsy or the need for anticonvulsant therapy.
- Major depressive disorder, anxiety, other mental disorders requiring medical correction.
- Acute cerebrovascular accident, stroke or transient ischemic attack within 90 days before screening.
- Administration of any antiviral and / or immunomodulatory drugs after the manifestation of COVID-19, with the exception of those specified in the MoH Temporary Guidelines.
- Any immunosuppressive therapy (including tocilizumab / sarilumab) within 90 days prior to randomization, or the need of immunosuppressive therapy at the time of randomization.
- Administration of systemic glucocorticosteroids within 90 days prior to randomization, or the need of systemic glucocorticosteroids at the time of randomization.
- Administration of vaccines against viral infections within 90 days prior to randomization.
- Patients receiving other experimental drugs, drugs not approved in the Russian Federation, or participating in other clinical trials within 30 days before screening.
- Patients abusing alcohol or psychotropic drugs and other drugs by the day of criteria assessment or during the last year.
- Patients with other serious, unstable, or clinically significant medical or psychological conditions that, in the opinion of the investigator, may preclude the patient's participation in the study.
- Expected death within 48 hours after randomization.
- Expected hospital discharge within 48 hours of randomization.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Russia5 sites
Municipal Budgetary Institution of Healthcare "Central City Hospital of Novoshakhtinsk"
Novoshakhtinsk, Rostov Oblast, 346918
Saint Petersburg State Budgetary Institution of Healthcare "City Hospital No. 40 of Kurortny District"
Saint Petersburg, 197706
Saint Petersburg State Budgetary Institution of Healthcare "City Pokrovskaya Hospital" (4th Cardiology Department)
Saint Petersburg, 199106
Saint Petersburg State Budgetary Institution of Healthcare "City Pokrovskaya Hospital"
Saint Petersburg, 199106
Regional State Budgetary Institution of Healthcare "Medical-Sanitary Unit No. 2"
Tomsk, 634040
About this study
Official title: A Multicenter, Adaptive, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of XC221, Tablets, 100 mg in Patients With COVID-19
The innovative drug XC221 100 mg tablet is designed for the treatment of COVID-19 (SARS-CoV-2 infection). A multicenter, adaptive, randomized, double-blind, placebo-controlled Phase III clinical study is aimed to assess the efficacy and safety of XC221 100 mg tablet, in COVID-19 patients during a 14-day treatment.
The primary objective of the study is to demonstrate the efficacy of XC221 100 mg tablet (200 mg daily dose) in achieving clinical improvement of COVID-19 symptoms.
The secondary objective of the study is to evaluate the safety of XC221 100 mg tablet (200 mg daily dose) in COVID-19 patients.
Read the detailed description
11 Russian centers will participate in this study. The trail will consist of three periods: screening (duration not more than 1 day, it may coincide with the randomization visit and beginning of drug administration), treatment period (14 days) and follow-up period (14 ± 1 days after completion of treatment with XC221 / Placebo). The duration of participation in the study for each patient will be no more than 30 days.
118 eligible patients with confirmed COVID-19 will be randomized into two groups (Group A and Group B) in a 1:1 ratio: Group A - XC221 200 mg daily (59 patients); Group В - Placebo (59 patients).
During the treatment period (14 days), 1 tablet of XC221 / Placebo will be administered 2 times a day in addition to the standard of care (SoC) for COVID-19 according to The Temporary guidelines for the prevention, diagnosis and treatment of SARS-CoV-2 infection of the Ministry of Health of the Russian Federation (the MoH Temporary Guidelines). The follow-up period will last for 14 days.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- XC221, Placebo
- Keywords
- COVID19, Coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XC221Drug
Participants will receive XC221 100 mg 2 times a day during 14 days
PlaceboDrug
Participants will receive Placebo 2 times a day during 14 days
| Study group | Role | What they receive |
|---|---|---|
| XC221 | Experimental | XC221 100 mg orally.
1 tablet of XC221 100 mg 2 times a day during 14 days of treatment period. Receives: Drug: XC221 |
| Placebo | Placebo comparator | Placebo orally.
1 tablet of Placebo 2 times a day during 14 days of treatment period Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient rate with a transition to category 3 or lower according to the WHO scale by Day 14 after the beginning of drug administration.
The scale of the patient's clinical condition, proposed by the WHO, will be used to assess the severity of patient general condition. Ranges for patient's clinical condition: 0 points (no infection) - 8 points (death).
Measured: Day 1 - Day 14
Secondary outcomes (42)
Time till clinical improvement, which is described by presence of all of the following factors during 48 hours in a row.
- Body temperature ≤ 37.5°C without using NSAIDs and / or paracetamol;
- RR ≤ 22 / min without oxygen therapy;
- SpO2 ≥ 95% without oxygen therapy.
Measured: Day 1 - Day 28
Patient rate with clinical improvement by day 2-28. Presence of all of the following factors during 48 hours in a row.
- Body temperature ≤ 37.5°C without using NSAIDs and / or paracetamol;
- RR ≤ 22 / min without oxygen therapy;
- SpO2 ≥ 95% without oxygen therapy.
Measured: Day 1 - Day 28
Patient rate with a negative test result for SARS-CoV-2 by Day 7±1, 15±1, 21 ±1 and 28 ± 1.
Measured: Day 1 - Day 28
Duration of hospitalization.
Measured: Day 1 - Day 28
Patient rate transferred to the intensive care unit (ICU) during hospitalization.
Measured: Day 1 - Day 28
Duration of ICU stay.
Measured: Day 1 - Day 28
Patient rate with ARDS during hospitalization.
Measured: Day 1 - Day 28
Presence of a fatal outcome.
Measured: Day 1 - Day 28
Patient rate requiring oxygen therapy by Day 2-28.
Measured: Day 1 - Day 28
Patient rate requiring high-flow oxygen therapy by Day 2-28.
Measured: Day 1 - Day 28
Patient rate requiring non-invasive ventilation by Day 2-28.
Measured: Day 1 - Day 28
Patient rate requiring invasive ventilation by Day 2-28.
Measured: Day 1 - Day 28
Patient rate requiring extracorporeal membrane oxygenation (EMO) by Day 2-28.
Measured: Day 1 - Day 28
The total duration of oxygen therapy by the last day of hospitalization.
Measured: Day 1 - Day 28
The total duration of high-flow oxygen therapy by the last day of hospitalization.
Measured: Day 1 - Day 28
The total duration of non-invasive ventilation by the last day of hospitalization.
Measured: Day 1 - Day 28
The total duration of invasive ventilation of lungs by the last day of hospitalization.
Measured: Day 1 - Day 28
The total duration of EMO by the last day of hospitalization.
Measured: Day 1 - Day 28
Patient rate with Sp02 > 95% by Day 2-28.
Measured: Day 1 - Day 28
Average alteration of Sp02 by Day 2-28 from baseline.
Measured: Day 1 - Day 28
Average time to reach SpO2 ≥ 95%.
Measured: Day 1 - Day 28
Patient rate with RR < 22 / min by Day 2-28.
Measured: Day 1 - Day 28
Average alteration in RR by Day 2-28 from baseline.
Measured: Day 1 - Day 28
Average time to reach RR ≤ 22 / min.
Measured: Day 1 - Day 28
Patient rate with body temperature < 37.5°C by Day 2-28.
Measured: Day 1 - Day 28
Average alteration in body temperature by Day 2-28 from baseline.
Measured: Day 1 - Day 28
Average time until the patient reaches a body temperature of ≤37.5°C.
Measured: Day 1 - Day 28
Patient rate with CT-1 according to CT data by Day 2-28.
Measured: Day 1 - Day 28
Average alteration in CT data by 1 point in terms of severity (CT-1, CT-2, CT-3, CT-4) by Day 7, 10, 15, 18, 21 and 28 compared to the baseline value.
Measured: Day 1 - Day 28
Average time to reach CT-1 according to CT data.
Measured: Day 1 - Day 28
Patient rate with a score < 2 according to the Daytime and Nighttime Cough Scale by Day 2-28.
The Daytime and Nighttime Cough Scale will be used to assess the dynamics of cough during the study. Ranges for assess: 0 points (no cough) - 6 points (severe cough that makes daytime activity impossible).
Measured: Day 1 - Day 28
Mean change in Daytime and Nighttime Cough scores by Day 2-28 from baseline.
The Daytime and Nighttime Cough Scale will be used to assess the dynamics of cough during the study. Ranges for assess: 0 points (no cough) - 6 points (severe cough that makes daytime activity impossible).
Measured: Day 1 - Day 28
Average time to reach < 2 points when assessed according to the Daytime and Nighttime Cough Scale.
The Daytime and Nighttime Cough Scale will be used to assess the dynamics of cough during the study. Ranges for assess: 0 points (no cough) - 6 points (severe cough that makes daytime activity impossible).
Measured: Day 1 - Day 28
Patient rate with a score < 1 for each symptom (general fatigue, chest congestion, sore throat, decreased sense of smell and taste, nasal congestion) according to a 4-point scale by Day 2-28.
The Symptom Rating Scale will be used to assess the individuals' subjective ratings the severity of 6 symptoms of COVID-19. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 18 points) is a sum of points for each symptom.
Measured: Day 1 - Day 28
Average change in score for each symptom (general fatigue, chest congestion, sore throat, decreased sense of smell and taste, nasal congestion) according to a 4-point scale by Day 2-28 from baseline.
The Symptom Rating Scale will be used to assess the individuals' subjective ratings the severity of 6 symptoms of COVID-19. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 18 points) is a sum of points for each symptom.
Measured: Day 1 - Day 28
Average time to reach a score of < 1 for each symptom (general fatigue, feeling of congestion in the chest, sore throat, decreased sense of smell and taste, nasal congestion) according to a 4-point scale.
The Symptom Rating Scale will be used to assess the individuals' subjective ratings the severity of 6 symptoms of COVID-19. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 18 points) is a sum of points for each symptom.
Measured: Day 1 - Day 28
Patient rate with a transition decrease to category 3 or lower according to the WHO scale by Day 2-13 and Day 15-28.
The scale of the patient's clinical condition, proposed by the WHO, will be used to assess the severity of patient general condition. Ranges for patient's clinical condition: 0 points (no infection) - 8 points (death).
Measured: Day 1 - Day 28
Mean WHO grade change by Day 2-28 from baseline.
The scale of the patient's clinical condition, proposed by the WHO, will be used to assess the severity of patient general condition. Ranges for patient's clinical condition: 0 points (no infection) - 8 points (death).
Measured: Day 1 - Day 28
Average time to reach the 3rd category or below according to the WHO scale.
The scale of the patient's clinical condition, proposed by the WHO, will be used to assess the severity of patient general condition. Ranges for patient's clinical condition: 0 points (no infection) - 8 points (death).
Measured: Day 1 - Day 28
Patient rate with a NEWS score < 2 by Day 2-28.
Parameters will be assessed according to the National Early Warning Score only during hospitalization. During the treatment period, the assessment will be performed 2 times a day. During the follow-up period, the assessment will be performed once a day. The worst result for each period is to be chosen.
Measured: Day 1 - Day 28
Average change in NEWS score by Day 2-28 from baseline.
Parameters will be assessed according to the National Early Warning Score only during hospitalization. During the treatment period, the assessment will be performed 2 times a day. During the follow-up period, the assessment will be performed once a day. The worst result for each period is to be chosen.
Measured: Day 1 - Day 28
Average time to reach a NEWS score ≤ 2.
Parameters will be assessed according to the National Early Warning Score only during hospitalization. During the treatment period, the assessment will be performed 2 times a day. During the follow-up period, the assessment will be performed once a day. The worst result for each period is to be chosen.
Measured: Day 1 - Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start25 Jul 2020
- Primary completion29 Oct 2020
- Study completion29 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- RSV Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487574
- Sponsor's protocol ID
- XC221-03-02-2020
- Status last verified
- Jul 2023
- First submitted
- 22 Jul 2020
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Adaptive, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of XC221, Tablets, 100 mg in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04487574
- Acronym / sponsor ID
- XC221-03-02-2020
- Conditions
- SARS-CoV-2 Infection
- Keywords
- COVID19, Coronavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- RSV Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2020 (actual)
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The innovative drug XC221 100 mg tablet is designed for the treatment of COVID-19 (SARS-CoV-2 infection). A multicenter, adaptive, randomized, double-blind, placebo-controlled Phase III clinical study is aimed to assess the efficacy and safety of XC221 100 mg tablet, in COVID-19 patients during a 14-day treatment.
The primary objective of the study is to demonstrate the efficacy of XC221 100 mg tablet (200 mg daily dose) in achieving clinical improvement of COVID-19 symptoms.
The secondary objective of the study is to evaluate the safety of XC221 100 mg tablet (200 mg daily dose) in COVID-19 patients.
Detailed description
11 Russian centers will participate in this study. The trail will consist of three periods: screening (duration not more than 1 day, it may coincide with the randomization visit and beginning of drug administration), treatment period (14 days) and follow-up period (14 ± 1 days after completion of treatment with XC221 / Placebo). The duration of participation in the study for each patient will be no more than 30 days.
118 eligible patients with confirmed COVID-19 will be randomized into two groups (Group A and Group B) in a 1:1 ratio: Group A - XC221 200 mg daily (59 patients); Group В - Placebo (59 patients).
During the treatment period (14 days), 1 tablet of XC221 / Placebo will be administered 2 times a day in addition to the standard of care (SoC) for COVID-19 according to The Temporary guidelines for the prevention, diagnosis and treatment of SARS-CoV-2 infection of the Ministry of Health of the Russian Federation (the MoH Temporary Guidelines). The follow-up period will last for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XC221 | Experimental | Drug: XC221XC221 100 mg orally. 1 tablet of XC221 100 mg 2 times a day during 14 days of treatment period. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo orally. 1 tablet of Placebo 2 times a day during 14 days of treatment period |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Signed Informed Consent Form.
- Patients of both sexes aged 18 to 75 years inclusive.
- Diagnosed COVID-19 based on:
- Patients with moderate or severe form of disease (t > 38.0°C; respiratory rate (RR) >22 / min; Sp02 <95%) not requiring non-invasive / invasive ventilation and / or high-flow oxygenation (HFNT), and / or extracorporeal membrane oxygenation (EMO) at the time of screening and randomization (based on the MoH Temporary Guidelines).
- Patients requiring oxygen therapy (oxygenation through a nasal cannula, a simple facemask or other similar oxygen delivery device) with a category "4" according to the WHO scale.
Key exclusion criteria (28 listed)
- Known or suspected hypersensitivity to the active substance or to excipients of the drug XC221 or placebo
- Known or suspected hypersensitivity to standard therapy drugs specified in The MoH Temporary Guidelines.
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
- Presence or suspicion of oncological diseases by the day of criteria assessment or in medical history (within the last 2 years).
- Presence of autoimmune diseases by the day of criteria assessment or in medical history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XC221Participants will receive XC221 100 mg 2 times a day during 14 days | Drug | XC221 |
| PlaceboParticipants will receive Placebo 2 times a day during 14 days | Drug | Placebo |
Primary outcome
Patient rate with a transition to category 3 or lower according to the WHO scale by Day 14 after the beginning of drug administration.
Time frame: Day 1 - Day 14
The scale of the patient's clinical condition, proposed by the WHO, will be used to assess the severity of patient general condition. Ranges for patient's clinical condition: 0 points (no infection) - 8 points (death).
42 secondary outcomes
Time till clinical improvement, which is described by presence of all of the following factors during 48 hours in a row.
Time frame: Day 1 - Day 28
Patient rate with clinical improvement by day 2-28. Presence of all of the following factors during 48 hours in a row.
Time frame: Day 1 - Day 28
Patient rate with a negative test result for SARS-CoV-2 by Day 7±1, 15±1, 21 ±1 and 28 ± 1.
Time frame: Day 1 - Day 28
Duration of hospitalization.
Time frame: Day 1 - Day 28
Patient rate transferred to the intensive care unit (ICU) during hospitalization.
Time frame: Day 1 - Day 28
Duration of ICU stay.
Time frame: Day 1 - Day 28
Patient rate with ARDS during hospitalization.
Time frame: Day 1 - Day 28
Presence of a fatal outcome.
Time frame: Day 1 - Day 28
Patient rate requiring oxygen therapy by Day 2-28.
Time frame: Day 1 - Day 28
Patient rate requiring high-flow oxygen therapy by Day 2-28.
Time frame: Day 1 - Day 28
Patient rate requiring non-invasive ventilation by Day 2-28.
Time frame: Day 1 - Day 28
Patient rate requiring invasive ventilation by Day 2-28.
Time frame: Day 1 - Day 28
Patient rate requiring extracorporeal membrane oxygenation (EMO) by Day 2-28.
Time frame: Day 1 - Day 28
The total duration of oxygen therapy by the last day of hospitalization.
Time frame: Day 1 - Day 28
The total duration of high-flow oxygen therapy by the last day of hospitalization.
Time frame: Day 1 - Day 28
The total duration of non-invasive ventilation by the last day of hospitalization.
Time frame: Day 1 - Day 28
The total duration of invasive ventilation of lungs by the last day of hospitalization.
Time frame: Day 1 - Day 28
The total duration of EMO by the last day of hospitalization.
Time frame: Day 1 - Day 28
Patient rate with Sp02 > 95% by Day 2-28.
Time frame: Day 1 - Day 28
Average alteration of Sp02 by Day 2-28 from baseline.
Time frame: Day 1 - Day 28
Average time to reach SpO2 ≥ 95%.
Time frame: Day 1 - Day 28
Patient rate with RR < 22 / min by Day 2-28.
Time frame: Day 1 - Day 28
Average alteration in RR by Day 2-28 from baseline.
Time frame: Day 1 - Day 28
Average time to reach RR ≤ 22 / min.
Time frame: Day 1 - Day 28
Patient rate with body temperature < 37.5°C by Day 2-28.
Time frame: Day 1 - Day 28
Average alteration in body temperature by Day 2-28 from baseline.
Time frame: Day 1 - Day 28
Average time until the patient reaches a body temperature of ≤37.5°C.
Time frame: Day 1 - Day 28
Patient rate with CT-1 according to CT data by Day 2-28.
Time frame: Day 1 - Day 28
Average alteration in CT data by 1 point in terms of severity (CT-1, CT-2, CT-3, CT-4) by Day 7, 10, 15, 18, 21 and 28 compared to the baseline value.
Time frame: Day 1 - Day 28
Average time to reach CT-1 according to CT data.
Time frame: Day 1 - Day 28
Patient rate with a score < 2 according to the Daytime and Nighttime Cough Scale by Day 2-28.
Time frame: Day 1 - Day 28
Mean change in Daytime and Nighttime Cough scores by Day 2-28 from baseline.
Time frame: Day 1 - Day 28
Average time to reach < 2 points when assessed according to the Daytime and Nighttime Cough Scale.
Time frame: Day 1 - Day 28
Patient rate with a score < 1 for each symptom (general fatigue, chest congestion, sore throat, decreased sense of smell and taste, nasal congestion) according to a 4-point scale by Day 2-28.
Time frame: Day 1 - Day 28
Average change in score for each symptom (general fatigue, chest congestion, sore throat, decreased sense of smell and taste, nasal congestion) according to a 4-point scale by Day 2-28 from baseline.
Time frame: Day 1 - Day 28
Average time to reach a score of < 1 for each symptom (general fatigue, feeling of congestion in the chest, sore throat, decreased sense of smell and taste, nasal congestion) according to a 4-point scale.
Time frame: Day 1 - Day 28
Patient rate with a transition decrease to category 3 or lower according to the WHO scale by Day 2-13 and Day 15-28.
Time frame: Day 1 - Day 28
Mean WHO grade change by Day 2-28 from baseline.
Time frame: Day 1 - Day 28
Average time to reach the 3rd category or below according to the WHO scale.
Time frame: Day 1 - Day 28
Patient rate with a NEWS score < 2 by Day 2-28.
Time frame: Day 1 - Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing XC221 in people with SARS-CoV-2 Infection, run by RSV Therapeutics LLC at 5 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient rate with a transition to category 3 or lower according to the WHO scale by Day 14 after the beginning of drug administration. (time frame: Day 1 - Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.