Post-acute COVID-19 SyndromePhase 3NCT05074888
Сlinical Trial of Efficacy and Safety of Prospekta in the Treatment of Post-COVID-19 Asthenia.
A Phase 3 study testing Prospekta in people with Post-acute COVID-19 Syndrome, run by Materia Medica Holding at 32 sites in Russia.
Trial summary
The multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial. The objective of this study is to evaluate the efficacy and safety of Prospekta in the treatment of asthenia in patients after the coronavirus infectious disease (COVID-19). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-acute COVID-19 Syndrome
- What is being tested?
- Prospekta
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 676 participants
- Where
- 32 sitesRussia
- Study dates
- 15 Oct 2021to 8 Jun 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults of either gender aged 18 to 65 years inclusive.
- Patients within 4-12 weeks of the confirmed COVID-19 onset .
- Symptoms of asthenia that appeared during or after an acute new coronavirus infection (COVID-19), persisting from 4 to 12 weeks from the onset of coronavirus infection.
- Presence of asthenia (≥36 on the FSS scale).
- Patients who agreed to use a reliable method of contraception during the study (for men and women with reproductive potential).
- Presence of a signed information sheet and informed consent form for participation in a clinical trial.
Who cannot join
- History / suspicion of cancer of any localization (with the exception of benign neoplasms).
- More than 75% of lung tissue damage during the period of COVID-19 disease (CT 4).
- Cerebrovascular diseases with the development of moderate to severe cognitive impairments.
- Uncontrolled arterial hypertension characterized by the following blood tension values: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg.
- Myocardial infarction, stroke in the previous 6 months.
- Nervous system disorders with persistent neurological impairment.
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- Autoimmune diseases.
- Decompensated diseases of the cardiovascular system, liver, kidney, gastrointestinal tract, and metabolic, respiratory, endocrine or hematological diseases, peripheral vascular disorders.
- Any severe comorbidity which, in the opinion of the investigator, may affect patient participation in the clinical trial.
- Hypersensitivity to any of the components of the study drug.
- Hereditary lactose intolerance, lactose malabsorption, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
- Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial (for men and women with reproductive potential).
- Patients, who, from the investigator's point of view, will not comply with study observation requirements or study drug administration procedures..
- Prior history of mental illness, alcoholism or drug abuse, that the investigator's opinion, will interfere with successful study procedures.
- Use of any medications listed in "Prohibited concomitant treatment" within 1 week before enrollment.
- Participation in other clinical studies within 3 months prior to enrollment in the study.
- Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. "Immediate relative" means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
- Participants who work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Russia32 sites
Belgorod Regional Clinical Hospital of St. Joasaph
Belgorod, 308007
Clinical hospital "RZD-Medicine" of Chelyabinsk city
Chelyabinsk, 454000
Ivanovo clinical hospital named after Kuvaevs/Polyclinic #10
Ivanovo, 153025
City Clinical Hospital # 9 of the Ministry of Health of the Udmurt Republic
Izhevsk, 426063
Kazan State Medical University, Department of Propedeutics of Internal Diseases named after prof. S.S. Zimnitsky
Kazan', 420012
Kazan State Medical University
Kazan', 420012
Kirov State Medical University, Hospital Therapy Department
Kirov, 610027
Kuban State Medical University, Infectious Diseases and Phthisiopulmonology
Krasnodar, 350063
Krasnogorsk city hospital #r 1
Krasnogorsk, 143408
City Clinical Hospital named after V.M. Buyanov of the Moscow City Health Department
Moscow, 115516
Central Clinical Hospital of the Russian Academy of Sciences
Moscow, 117593
Llc "Verum Medical"
Moscow, 119285
Moscow State Medical and Dental University named after A.I. Evdokimov, Department of Faculty Therapy and Occupational Diseases
Moscow, 127473
Nizhny Novgorod Research Institute of Hygiene and Occupational Pathology
Nizhny Novgorod, 603005
Llc "Nizhmedklinika"
Nizhny Novgorod, 603159
City Emergency Hospital of Rostov-on-Don
Rostov-on-Don, 344068
Ryazan State Medical University named after acad. I.P. Pavlov, Department of Outpatient Therapy and Preventive Medicine
Ryazan, 390026
Llc "Ava-Peter"
Saint Petersburg, 191014
LLC "Energy of Health"
Saint Petersburg, 194156
LLC Medical center" Reavita Med SPb "
Saint Petersburg, 194354
City polyclinic # 51
Saint Petersburg, 196211
City Polyclinic # 34
Saint Petersburg, 197198
Saratov State Medical University named after V. I. Razumovsky, Neurology Department named after K.N. Tretyakov
Saratov, 410012
LLC "Scientific Medical Center for General Therapy and Pharmacology"
Stavropol, 355000
Bashkir State Medical University, Internal Medicine Department
Ufa, 450008
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, 432063
Vsevolozhsk clinical interdistrict hospital
Vsevolozhsk, 188643
LLC "Center for Medical Consulting and Research - PRACTICE"
Yaroslavl, 150003
Clinical Hospital # 2
Yaroslavl, 150030
Clinical Hospital # 9
Yaroslavl, 150042
LLC "Family Clinic"
Yekaterinburg, 620109
Central city hospital # 7
Yekaterinburg, 620137
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled, Parallel-group, Randomized Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Patients With Post-COVID-19 Asthenia.
The multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.
The objective of this study is to evaluate the efficacy and safety of Prospekta in the treatment of asthenia in patients after the coronavirus infectious disease (COVID-19).
Read the detailed description
Design: the multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.
The study will enroll adult patients of either gender aged 18 to 65 years after new coronavirus infection of 2019 (COVID-19) with symptoms of asthenia that appeared during or after an acute coronavirus infection (COVID-19) and persisting 4 to 12 weeks from the onset of coronavirus infection.
After the patient signs the patient information sheet and the informed consent form for participation in the study, complaints, medical history, physical examination, registration of vital signs are collected, the patient fills in the Fatigue Severity Scale (FSS) and Hospital Anxiety and Depression Scale (HADS). A six-minute walk test (6MWT) is carried out. The physician evaluates the severity of asthenia with FSS scale and records concomitant medications, co-morbidities and concurrent conditions.
If a patient meets all inclusion criteria and does not have any of the exclusion criteria at Visit 1 (Day 1), he/she is randomized to one of two groups: Group 1 - patients receive Prospekta at a dose of 1 tablet twice daily for 4 weeks; Group 2 - patients receive placebo on the study drug regimen.
The trial will use electronic patient diaries (EPD). The patient should record any possible deterioration (if applicable) in the EPD. At Visit 1 (Day 1), the physician will provide guidance on how to work with EPD, so that the patient can use it independently in the future.
At Visit 2 (Week 4 ± 3 days), the physician will collect patient's complaints, record physical examination data and vital signs as well as any changes in concurrent diseases and conditions. The patient fills out the FSS and HADS scales. A 6MWT is carried out. The physician monitors the prescribed treatment and use of concomitant medications, evaluates the safety of the study treatment and patient's compliance, filling out the diary.
The patient stops taking the study drug. At the end of the study treatment period, the patient is monitored for 4 weeks (follow-up period).
At Visit 3 (final visit, Week 8 ± 3 days), the physician collects patient's complaints, records physical examination data and vital signs, changes in concomitant diseases and conditions. The patient fills in the FSS and HADS scales. A 6MWT is carried out. The physician evaluates the safety of the study treatment, checks the completion of the diary.
During the study the patients are allowed to take medications for their chronic conditions, except for medicines listed as "Prohibited concomitant treatment".
- Conditions
- Post-acute COVID-19 Syndrome
- Being tested
- Prospekta, Placebo
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProspektaDrug
Oral administration.
PlaceboDrug
Oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Prospekta | Experimental | Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. Receives: Drug: Prospekta |
| Placebo | Placebo comparator | Tablet for oral use. Placebo using Prospekta scheme. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Mean FSS Score.
Fatigue Severity Scale (FSS). Change in the mean FSS score after 4 weeks of treatment. The total score of the scale, which consists of 9 questions, varies between 9-63. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period. A total of 36 points and above indicate fatigue. A higher score is indicated high level of fatigue.
Measured: after 4 weeks of treatment
Secondary outcomes (14)
Change in Distance of the 6-minute Walk Test.
Change in distance when performing the 6-minute walk test after 4 weeks of treatment. The test is carried out with the aim of objectively assessing the patient's physical tolerance. The patient should walk the maximum possible distance for himself at his own pace on a flat surface in 6 minutes.
Measured: after 4 weeks of treatment
Change in the Severity of Anxiety on the HADS Subscale.
Hospital Anxiety and Depression Scale (HADS). Change in the severity of anxiety and depression on the HADS subscales after 4 weeks of treatment. The scale is composed of 14 statements serving 2 subscales: "anxiety" (odd items - 1, 3, 5, 7, 9, 11, 13) and "depression" (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values:
0-7 - "norm" (absence of reliably expressed symptoms of anxiety and depression); 8-10 - "subclinical anxiety / depression"; 11 and above - "clinical anxiety / depression". The anxiety subscale ranges from 0 to 21, with higher values reflecting a worse outcome.
Measured: after 4 weeks of treatment
Change in the Severity of Depression on the HADS Subscale.
Hospital Anxiety and Depression Scale (HADS). Change in the severity of depression on the HADS subscale after 4 weeks of treatment. The scale is composed of 14 statements serving 2 subscales: "anxiety" (odd items - 1, 3, 5, 7, 9, 11, 13) and "depression" (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values:
0-7 - "norm" (absence of reliably expressed symptoms of anxiety and depression); 8-10 - "subclinical anxiety / depression"; 11 and above - "clinical anxiety / depression". The depression subscale ranges from 0 to 21, with higher values reflecting a worse outcome.
Measured: after 4 weeks of treatment
Change in the Mean FSS Score Within Follow-up Period.
Change in mean FSS score over 4 weeks of follow-up period at the end of treatment. The total score of the scale, which consists of 9 questions, varies between 9-63. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period. A total of 36 points and above indicate fatigue. A higher score is indicated high level of fatigue.
Measured: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
Change in Distance of the 6-minute Walk Test Within Follow-up Period.
Change in distance when performing the 6-minute walk test over a 4-week follow-up period at the end of treatment. The test is carried out with the aim of objectively assessing the patient's physical tolerance. The patient should walk the maximum possible distance for himself at his own pace on a flat surface in 6 minutes.
Measured: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
Change in the Severity of Anxiety on the HADS Subscales Within Follow-up Period.
Change in the severity of anxiety on the HADS subscales over a 4-week follow-up period at the end of treatment. The scale is composed of 14 statements serving 2 subscales: "anxiety" (odd items - 1, 3, 5, 7, 9, 11, 13) and "depression" (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values:
0-7 - "norm" (absence of reliably expressed symptoms of anxiety and depression); 8-10 - "subclinical anxiety / depression"; 11 and above - "clinical anxiety / depression". The anxiety subscale ranges from 0 to 21, with higher values reflecting a worse outcome.
Measured: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
Change in the Severity of Depression on the HADS Subscales Within Follow-up Period.
Change in the severity of depression on the HADS subscales over a 4-week follow-up period at the end of treatment.
The scale is composed of 14 statements serving 2 subscales: "anxiety" (odd items - 1, 3, 5, 7, 9, 11, 13) and "depression" (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values:
0-7 - "norm" (absence of reliably expressed symptoms of anxiety and depression); 8-10 - "subclinical anxiety / depression"; 11 and above - "clinical anxiety / depression". The depression subscale ranges from 0 to 21, with higher values reflecting a worse outcome.
Measured: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
Changes in Vital Signs (Pulse Rate (Heart Rate)).
Based on medical records. Vital signs will be measured in a medical setting.
Measured: after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment.
Changes in Vital Signs (Respiration Rate (Breathing Rate)).
Based on medical records. Vital signs will be measured in a medical setting.
Measured: after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment (Visit 1: baseline, Visit 2: after 4 weeks of treatment, and Visit 3: after 4 weeks of follow-up at week 8)
Changes in Vital Signs (Blood Pressure).
Based on medical records. Vital signs will be measured in a medical setting.
Measured: after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment (Visit 1: baseline, Visit 2: after 4 weeks of treatment, and Visit 3: after 4 weeks of follow-up at week 8).
Presence of Adverse Events (AEs).
The number of participants with adverse events (AEs). Based on medical records.
Measured: 8 weeks
The Severity of AEs.
The intensity (severity) of adverse events. Based on medical records.
Measured: 8 weeks
The Outcome of AEs.
The outcome of adverse events. Based on medical records.
Measured: 8 weeks
AEs Causal Relationship to the Study Drug.
The adverse events causal relationship to the study drug. Based on medical records.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start15 Oct 2021
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-acute COVID-19 SyndromeStudies 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
- Model description
- double-blind, placebo-controlled, parallel-group, randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 676 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074888
- Sponsor's protocol ID
- MMH-MAP-006
- Status last verified
- Jan 2023
- First submitted
- 5 Oct 2021
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo-controlled, Parallel-group, Randomized Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Patients With Post-COVID-19 Asthenia.
- ClinicalTrials.gov ID
- NCT05074888
- Acronym / sponsor ID
- MMH-MAP-006
- Conditions
- Post-acute COVID-19 Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 676 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.
The objective of this study is to evaluate the efficacy and safety of Prospekta in the treatment of asthenia in patients after the coronavirus infectious disease (COVID-19).
Detailed description
Design: the multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.
The study will enroll adult patients of either gender aged 18 to 65 years after new coronavirus infection of 2019 (COVID-19) with symptoms of asthenia that appeared during or after an acute coronavirus infection (COVID-19) and persisting 4 to 12 weeks from the onset of coronavirus infection.
After the patient signs the patient information sheet and the informed consent form for participation in the study, complaints, medical history, physical examination, registration of vital signs are collected, the patient fills in the Fatigue Severity Scale (FSS) and Hospital Anxiety and Depression Scale (HADS). A six-minute walk test (6MWT) is carried out. The physician evaluates the severity of asthenia with FSS scale and records concomitant medications, co-morbidities and concurrent conditions.
If a patient meets all inclusion criteria and does not have any of the exclusion criteria at Visit 1 (Day 1), he/she is randomized to one of two groups: Group 1 - patients receive Prospekta at a dose of 1 tablet twice daily for 4 weeks; Group 2 - patients receive placebo on the study drug regimen.
The trial will use electronic patient diaries (EPD). The patient should record any possible deterioration (if applicable) in the EPD. At Visit 1 (Day 1), the physician will provide guidance on how to work with EPD, so that the patient can use it independently in the future.
At Visit 2 (Week 4 ± 3 days), the physician will collect patient's complaints, record physical examination data and vital signs as well as any changes in concurrent diseases and conditions. The patient fills out the FSS and HADS scales. A 6MWT is carried out. The physician monitors the prescribed treatment and use of concomitant medications, evaluates the safety of the study treatment and patient's compliance, filling out the diary.
The patient stops taking the study drug. At the end of the study treatment period, the patient is monitored for 4 weeks (follow-up period).
At Visit 3 (final visit, Week 8 ± 3 days), the physician collects patient's complaints, records physical examination data and vital signs, changes in concomitant diseases and conditions. The patient fills in the FSS and HADS scales. A 6MWT is carried out. The physician evaluates the safety of the study treatment, checks the completion of the diary.
During the study the patients are allowed to take medications for their chronic conditions, except for medicines listed as "Prohibited concomitant treatment".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind, placebo-controlled, parallel-group, randomized
| Arm | Type | Receives |
|---|---|---|
| Prospekta | Experimental | Drug: ProspektaTablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved. |
| Placebo | Placebo comparator | Drug: PlaceboTablet for oral use. Placebo using Prospekta scheme. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults of either gender aged 18 to 65 years inclusive.
- Patients within 4-12 weeks of the confirmed COVID-19 onset .
- Symptoms of asthenia that appeared during or after an acute new coronavirus infection (COVID-19), persisting from 4 to 12 weeks from the onset of coronavirus infection.
- Presence of asthenia (≥36 on the FSS scale).
- Patients who agreed to use a reliable method of contraception during the study (for men and women with reproductive potential).
Key exclusion criteria (18 listed)
- History / suspicion of cancer of any localization (with the exception of benign neoplasms).
- More than 75% of lung tissue damage during the period of COVID-19 disease (CT 4).
- Cerebrovascular diseases with the development of moderate to severe cognitive impairments.
- Uncontrolled arterial hypertension characterized by the following blood tension values: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg.
- Myocardial infarction, stroke in the previous 6 months.
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 |
|---|---|---|
| ProspektaOral administration. | Drug | Prospekta |
| PlaceboOral administration. | Drug | Placebo |
Primary outcome
Change in the Mean FSS Score.
Time frame: after 4 weeks of treatment
Fatigue Severity Scale (FSS). Change in the mean FSS score after 4 weeks of treatment. The total score of the scale, which consists of 9 questions, varies between 9-63. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period. A total of 36 points and above indicate fatigue. A higher score is indicated high level of fatigue.
14 secondary outcomes
Change in Distance of the 6-minute Walk Test.
Time frame: after 4 weeks of treatment
Change in the Severity of Anxiety on the HADS Subscale.
Time frame: after 4 weeks of treatment
Change in the Severity of Depression on the HADS Subscale.
Time frame: after 4 weeks of treatment
Change in the Mean FSS Score Within Follow-up Period.
Time frame: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
Change in Distance of the 6-minute Walk Test Within Follow-up Period.
Time frame: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
Change in the Severity of Anxiety on the HADS Subscales Within Follow-up Period.
Time frame: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
Change in the Severity of Depression on the HADS Subscales Within Follow-up Period.
Time frame: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
Changes in Vital Signs (Pulse Rate (Heart Rate)).
Time frame: after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment.
Changes in Vital Signs (Respiration Rate (Breathing Rate)).
Time frame: after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment (Visit 1: baseline, Visit 2: after 4 weeks of treatment, and Visit 3: after 4 weeks of follow-up at week 8)
Changes in Vital Signs (Blood Pressure).
Time frame: after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment (Visit 1: baseline, Visit 2: after 4 weeks of treatment, and Visit 3: after 4 weeks of follow-up at week 8).
Presence of Adverse Events (AEs).
Time frame: 8 weeks
The Severity of AEs.
Time frame: 8 weeks
The Outcome of AEs.
Time frame: 8 weeks
AEs Causal Relationship to the Study Drug.
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
32 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 Prospekta in people with Post-acute COVID-19 Syndrome, run by Materia Medica Holding at 32 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 6 inclusion and 18 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 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in the Mean FSS Score. (time frame: after 4 weeks of treatment). 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 23 Sep 2024.