SARS-CoV-2Phase 2CYCLOVIDNCT04608214
Evaluation of Alisporivir for the Treatment of Hospitalised Patients With Infections Due to SARS-CoV-2 (COVID-19)
A Phase 2 study testing Alisporivir in people with SARS-CoV-2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
COVID-19 is a viral respiratory and systemic disease that has been rapidly spreading globally since the first cases were reported in December 2019 and has now become pandemic. The causative agent of COVID-19 was identified as a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, first… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Alisporivir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2021to 13 Apr 2022
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females ≥18 years and ≤80 years of age at the time of screening.
- Are hospitalised during the screening period with duration of hospitalisation prior to randomisation ≤48 hours.
- Have a diagnosis of COVID-19 based on symptoms onset and positive SARS-CoV-2 RT-PCR test from nasopharyngeal swab.
- Viral load ≤ 30 Ct
- Have at least one (1) of the following:
- Radiographic pulmonary infiltrates (CT scan), AND/OR
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- Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤94% on room air, AND/OR
- Requirement for supplemental oxygen.
- If female, of non-childbearing potential or if of childbearing potential, be willing to commit to either sexual abstinence or use of at least 2 medically accepted, effective methods of birth control from screening through 2 months after last alisporivir dose.
- If male, a willingness to refrain from donating sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, a willingness to use a condom in addition to having the female partner use a highly effective method of birth control from screening through 4 months after last alisporivir dose.
- Willing and able to provide written informed consent.
- Willing to comply with all study assessments and adhere to the protocol schedule.
- Has an affiliation with a social security system.
Who cannot join
- Patients requiring mechanical ventilation at screening or randomisation.
- In the opinion of the investigator, the patient is unlikely to survive the following 7 days after randomisation due to a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock.
- Patients who are unconscious or considered by the investigator unable to consent.
- Other severe co-morbidity with life expectancy ≤3 months according to the investigator's assessment.
- Critically ill patients who have an APACHE II score ≥30.
- Concomitant severe bacterial infection including blood stream infections, endocarditis, osteomyelitis, retroperitoneal abscess, septic arthritis, or meningitis diagnosed within 7 days prior to randomisation (bacterial pulmonary infection that may complicate COVID-19 is not an exclusion criterion).
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- Any of the following signs of severe sepsis:
- Shock or profound hypotension defined as systolic blood pressure ≤90 mm Hg or a decrease of ≥40 mm Hg from the value obtained during screening that is not responsive to fluid challenge.
- Hypothermia (core temperature ≤ 35.6°C).
- Disseminated intravascular coagulation (DIC) as evidenced by PT, PTT 2 × upper limit of normal (ULN), or platelets ≤ 50% of the lower limit of normal (LLN).
- History of positive test for human immunodeficiency virus (HIV) including all patients currently on highly active antiretroviral therapy (HAART) regardless of the CD4+ cell count.
- Presence of immunodeficiency or an immunocompromised condition including neutropenia, haematologic malignancy, history of haematopoietic stem cell transplant, history of solid organ transplant, receiving immunosuppressive therapy and long term use of systemic corticosteroids.
- Severe hepatic impairment at screening, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 5 × ULN or total bilirubin ≥2 × ULN (except in case of known Gilbert syndrome), or clinical signs of decompensated cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy).
- Acute hepatitis, decompensated cirrhosis (any Child-Pugh B or C class), acute hepatic failure or acute decompensation of chronic hepatic failure.
- Severe renal impairment (creatinine-clearance ≤30 mL/min) or end-stage renal disease (ESRD) requiring haemodialysis or peritoneal dialysis, according to Cockcroft-Gault.
- Uncontrolled hypertension that is not responsive to treatment.
- Uncontrolled thyroid function (Thyroid Stimulating Hormone [TSH] outside of normal ranges).
- History of epilepsy or known seizure disorder (excluding a history of childhood febrile seizures).
- Acute co-morbidity within 7 days before inclusion such as myocardial infarction.
- A female who is pregnant or breastfeeding.
- Documented hypersensitivity reaction or anaphylaxis to alisporivir, one of the non-active ingredients or any of the SOC medications.
- Receipt of any investigational medication in the 3 months prior to screening.
- Anticipated transfer to another hospital that is not a study site during the first 4 days of treatment.
- Patients previously treated with antivirals, immunomodulators (mAbs in the 3 months prior to screening) and other medicines prohibited in this study in the 14 days prior to randomisation.
- Ongoing or recent use of any other medication (including over the counter medication and herbal products) within 14 days before randomisation or within 5 drug half-lives of that medication (whichever is longer) that are known inhibitors/inducers of cytochrome P450 3A or P-glycoprotein (P-gp), or inhibitors of organic anion transporting polypeptides (OATPs), multi resistance protein 2 (MRP2) or bile salt export pump (BSEP).
- Known need of concomitant treatment with the following medications during treatment with alisporivir and 14 days after the end of treatment:
- Known inhibitors/inducers of cytochrome P450 3A or P-gp, or inhibitors of OATPs, MRP2 or BSEP;
- Drugs with narrow therapeutic index that are known sensitive substrates of cytochrome P450 3A, or substrates of P-gp, OATPs, MRP2 or BSEP.
- Any other condition or prior therapy, which, in the opinion of the investigator, would make the patient unsuitable for this study.
- Patients with history of pancreatic disease.
- Patients under legal protection.
- Prisoners.
- Patients participating in another interventional study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy, Safety and Tolerability of Alisporivir for the Treatment of Hospitalised Patients With Infections Due to SARS-CoV-2 (COVID-19). A Randomised, Open-label, Proof of Concept, Phase 2 Study
COVID-19 is a viral respiratory and systemic disease that has been rapidly spreading globally since the first cases were reported in December 2019 and has now become pandemic. The causative agent of COVID-19 was identified as a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, first designated as 2019-nCoV).
The disease manifestations of COVID-19 can range from mild, self-resolving respiratory disease to severe pneumonia, ARDS, multiorgan failure, and ultimately death. In early reports, the mortality rate among patients admitted to hospital and with confirmed SARS-CoV-2 infection was reported to be between 4 and 15%. Although the disease can afflict all age groups, elderly patients and patients with underlying comorbidities such as high body mass index, hypertension, diabetes, cardiovascular disease, or cerebrovascular disease are at risk of developing severe disease and dying.
There are currently no etiologic treatments for COVID-19, and efforts are underway to identify therapeutics that could be effective in controlling this disease.
Read the detailed description
Cyclophilins are cellular (host) peptidyl-prolyl cis/trans isomerases (molecular chaperones) involved in protein folding, maturation, and trafficking. Cyclophilins have been shown to play a key role in the lifecycle of many coronaviruses, including human coronaviruses 229E (HCoV-229E) and NL-63 (HCoV-NL63), feline infectious peritonitis coronavirus (FPIV), SARS-CoV and Middle-East-Respiratory-Syndrome coronavirus (MERS-CoV). Cyclosporin A (CsA), a potent cyclophilin inhibitor, blocks the replication of various coronaviruses in vitro, including HCoV-229E, HCoV-NL63, FPIV, mouse hepatitis virus (MHV), avian infectious bronchitis virus, and SARS-CoV.
Alisporivir is a non-immunosuppressive analogue of CsA with potent cyclophilin inhibition properties. In vitro, alisporivir inhibits the replication of HCoV-229E, HCoV-NL63, MHV, SARS-CoV and MERS-CoV at low micromolar concentrations without cytotoxic effect. Although alisporivir has not demonstrated activity against coronaviruses in in vivo models to date, recent experiments showed that alisporivir bears concentration-dependent properties against CoV-2 in vitro.
Preclinical pharmacology data indicate that, after oral administration, alisporivir is widely distributed in the whole body, including the lungs. Furthermore, the EC90 of alisporivir against SARS-CoV-2 in VeroE6 cells appears to be clinically achievable in patients. In addition, because alisporivir inhibits all cellular cyclophilins, it also blocks mitochondrial cyclophilin-D, a key regulator of mitochondrial permeability transition pore (mPTP) opening, a mechanism involved in triggering cell death.
Therefore, besides its antiviral properties, alisporivir may also be effective in preventing lung tissue damage.
- Conditions
- SARS-CoV-2
- Being tested
- Alisporivir, Standard of care (SOC)
- Keywords
- Alisporivir, Viral Load, efficacy, safety, tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlisporivirDrug
Administration of alisporivir at the dose of 600 mg p.o. BID from D1 to D14 to patients and standard of care (SOC).
Standard of care (SOC)Other
Locally accepted regimen protocols for patient care and select agents based on the underlying diagnosis and the severity of COVID 19 (excepting e.g. azithromycin and other antibiotics listed as prohibited medications)
| Study group | Role | What they receive |
|---|---|---|
| Alisporivir | Experimental | Administration of alisporivir and standard of care (SOC) Receives: Drug: Alisporivir |
| Standard of care (SOC) | Active comparator | Locally accepted regimen protocols for patient care Receives: Other: Standard of care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SARS-CoV-2 viral load in nasopharyngeal swabs
Measured: at Day 1 and Day 7
Secondary outcomes (33)
Viral Load Response Rate (VLRR)
Measured: at Day 1 and Day 7
Percentage of patients reporting each severity rating on an 8-point ordinal scale.
Measured: at Day 1, Day4, Day 7, Day 11, Day 14 and Day 90
Change in National Early Warning Score scale
Measured: at Day 1, Day 4, Day 7, Day 11, Day 14 and Day 90
Changes in thoracic CT scan
Measured: screening to Day 1, Day 14 and Day 90
Percentage of patients admitted to Intensive Care Unit (ICU)
Measured: at Day 1 to Day 28
Time to admission to Intensive Care Unit (ICU)
Measured: at Day 1 to Day 28
Percentage of patients admitted to Intensive Care Unit (ICU)
Measured: at Day 90
Time to admission to Intensive Care Unit (ICU)
Measured: at Day 90
Percentage of patients requiring mechanical ventilation
Measured: at Day 1 to Day 28
Percentage of patients requiring mechanical ventilation
Measured: at Day 90
Percentages of patients negative for SARS CoV 2 RNA in nasopharyngeal swabs
Measured: at Day 14, Day 21 and Day 28
Time to negative viral load
Measured: at Day 1 to Day 28
Time to resolution of symptoms
Measured: at Day 1 to Day 28
Time to resolution of symptoms
Measured: at Day 90
Duration of need for supplemental oxygen
Measured: at Day 1 to Day 28
Duration of need for supplemental oxygen
Measured: at Day 90
Duration of hospitalisation
Measured: at Day 1 to Day 28
Duration of hospitalisation
Measured: at Day 90
Duration of new non-invasive ventilation or high flow oxygen use
Measured: at Day 1 to Day 28
Duration of new non-invasive ventilation or high flow oxygen use
Measured: at Day 90
Duration of new oxygen use
Measured: at Day 1 to Day 28
Duration of new oxygen use
Measured: at Day 90
Duration of new ventilator or ECMO use
Measured: at Day 1 to Day 28
Duration of new ventilator or ECMO use
Measured: at Day 90
Number of non-invasive ventilation/high flow oxygen free days
Measured: at Day 1 to Day 28
Number of non-invasive ventilation/high flow oxygen free days
Measured: at Day 90
Number of oxygenation free days
Measured: at Day 1 to Day 28
Number of oxygenation free days
Measured: at Day 90
Patient all-cause mortality
Measured: at Day 14, Day 28 and Day 90
Cumulative incidence of any AE
Measured: at Day 1 to Day 90
Cumulative incidence of Grade 3 and 4 AEs
Measured: at Day 1 to Day 90
Cumulative incidence of SAEs
Measured: at Day 1 to Day 90
Percentage of re-hospitalization
Measured: Hospital discharge to D90 ±2d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start8 Jan 2021
- Primary completion19 Jan 2022
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomised, open-label, proof of-concept, Phase 2 study to evaluate the efficacy, safety and tolerability of alisporivir plus SOC as compared to SOC for the treatment of hospitalised patients with infections due to SARS-CoV-2
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Debiopharm International SA
- Responsible party
- Sponsor
- Investigators
- Jean-Michel PAWLOTSKY, MD, PhD, Study director, Assistance Publique Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608214
- Sponsor's protocol ID
- APHP200552
- Other IDs
- 2020-002295-13
- Acronym
- CYCLOVID
- Status last verified
- Apr 2023
- First submitted
- 12 Oct 2020
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy, Safety and Tolerability of Alisporivir for the Treatment of Hospitalised Patients With Infections Due to SARS-CoV-2 (COVID-19). A Randomised, Open-label, Proof of Concept, Phase 2 Study
- ClinicalTrials.gov ID
- NCT04608214
- Acronym / sponsor ID
- CYCLOVID / APHP200552
- Conditions
- SARS-CoV-2
- Keywords
- Alisporivir, Viral Load, efficacy, safety, tolerability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Debiopharm International SA
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 29 Oct 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.
COVID-19 is a viral respiratory and systemic disease that has been rapidly spreading globally since the first cases were reported in December 2019 and has now become pandemic. The causative agent of COVID-19 was identified as a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, first designated as 2019-nCoV).
The disease manifestations of COVID-19 can range from mild, self-resolving respiratory disease to severe pneumonia, ARDS, multiorgan failure, and ultimately death. In early reports, the mortality rate among patients admitted to hospital and with confirmed SARS-CoV-2 infection was reported to be between 4 and 15%. Although the disease can afflict all age groups, elderly patients and patients with underlying comorbidities such as high body mass index, hypertension, diabetes, cardiovascular disease, or cerebrovascular disease are at risk of developing severe disease and dying.
There are currently no etiologic treatments for COVID-19, and efforts are underway to identify therapeutics that could be effective in controlling this disease.
Detailed description
Cyclophilins are cellular (host) peptidyl-prolyl cis/trans isomerases (molecular chaperones) involved in protein folding, maturation, and trafficking. Cyclophilins have been shown to play a key role in the lifecycle of many coronaviruses, including human coronaviruses 229E (HCoV-229E) and NL-63 (HCoV-NL63), feline infectious peritonitis coronavirus (FPIV), SARS-CoV and Middle-East-Respiratory-Syndrome coronavirus (MERS-CoV). Cyclosporin A (CsA), a potent cyclophilin inhibitor, blocks the replication of various coronaviruses in vitro, including HCoV-229E, HCoV-NL63, FPIV, mouse hepatitis virus (MHV), avian infectious bronchitis virus, and SARS-CoV.
Alisporivir is a non-immunosuppressive analogue of CsA with potent cyclophilin inhibition properties. In vitro, alisporivir inhibits the replication of HCoV-229E, HCoV-NL63, MHV, SARS-CoV and MERS-CoV at low micromolar concentrations without cytotoxic effect. Although alisporivir has not demonstrated activity against coronaviruses in in vivo models to date, recent experiments showed that alisporivir bears concentration-dependent properties against CoV-2 in vitro.
Preclinical pharmacology data indicate that, after oral administration, alisporivir is widely distributed in the whole body, including the lungs. Furthermore, the EC90 of alisporivir against SARS-CoV-2 in VeroE6 cells appears to be clinically achievable in patients. In addition, because alisporivir inhibits all cellular cyclophilins, it also blocks mitochondrial cyclophilin-D, a key regulator of mitochondrial permeability transition pore (mPTP) opening, a mechanism involved in triggering cell death.
Therefore, besides its antiviral properties, alisporivir may also be effective in preventing lung tissue damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomised, open-label, proof of-concept, Phase 2 study to evaluate the efficacy, safety and tolerability of alisporivir plus SOC as compared to SOC for the treatment of hospitalised patients with infections due to SARS-CoV-2
| Arm | Type | Receives |
|---|---|---|
| Alisporivir | Experimental | Drug: AlisporivirAdministration of alisporivir and standard of care (SOC) |
| Standard of care (SOC) | Active comparator | Other: Standard of care (SOC)Locally accepted regimen protocols for patient care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult males and females ≥18 years and ≤80 years of age at the time of screening.
- Are hospitalised during the screening period with duration of hospitalisation prior to randomisation ≤48 hours.
- Have a diagnosis of COVID-19 based on symptoms onset and positive SARS-CoV-2 RT-PCR test from nasopharyngeal swab.
- Viral load ≤ 30 Ct
- Have at least one (1) of the following:
Key exclusion criteria (33 listed)
- Patients requiring mechanical ventilation at screening or randomisation.
- In the opinion of the investigator, the patient is unlikely to survive the following 7 days after randomisation due to a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock.
- Patients who are unconscious or considered by the investigator unable to consent.
- Other severe co-morbidity with life expectancy ≤3 months according to the investigator's assessment.
- Critically ill patients who have an APACHE II score ≥30.
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 |
|---|---|---|
| AlisporivirAdministration of alisporivir at the dose of 600 mg p.o. BID from D1 to D14 to patients and standard of care (SOC). | Drug | Alisporivir |
| Standard of care (SOC)Locally accepted regimen protocols for patient care and select agents based on the underlying diagnosis and the severity of COVID 19 (excepting e.g. azithromycin and other antibiotics listed as prohibited medications) | Other | Standard of care (SOC) |
Primary outcome
Change in SARS-CoV-2 viral load in nasopharyngeal swabs
Time frame: at Day 1 and Day 7
33 secondary outcomes
Viral Load Response Rate (VLRR)
Time frame: at Day 1 and Day 7
Percentage of patients reporting each severity rating on an 8-point ordinal scale.
Time frame: at Day 1, Day4, Day 7, Day 11, Day 14 and Day 90
Change in National Early Warning Score scale
Time frame: at Day 1, Day 4, Day 7, Day 11, Day 14 and Day 90
Changes in thoracic CT scan
Time frame: screening to Day 1, Day 14 and Day 90
Percentage of patients admitted to Intensive Care Unit (ICU)
Time frame: at Day 1 to Day 28
Time to admission to Intensive Care Unit (ICU)
Time frame: at Day 1 to Day 28
Percentage of patients admitted to Intensive Care Unit (ICU)
Time frame: at Day 90
Time to admission to Intensive Care Unit (ICU)
Time frame: at Day 90
Percentage of patients requiring mechanical ventilation
Time frame: at Day 1 to Day 28
Percentage of patients requiring mechanical ventilation
Time frame: at Day 90
Percentages of patients negative for SARS CoV 2 RNA in nasopharyngeal swabs
Time frame: at Day 14, Day 21 and Day 28
Time to negative viral load
Time frame: at Day 1 to Day 28
Time to resolution of symptoms
Time frame: at Day 1 to Day 28
Time to resolution of symptoms
Time frame: at Day 90
Duration of need for supplemental oxygen
Time frame: at Day 1 to Day 28
Duration of need for supplemental oxygen
Time frame: at Day 90
Duration of hospitalisation
Time frame: at Day 1 to Day 28
Duration of hospitalisation
Time frame: at Day 90
Duration of new non-invasive ventilation or high flow oxygen use
Time frame: at Day 1 to Day 28
Duration of new non-invasive ventilation or high flow oxygen use
Time frame: at Day 90
Duration of new oxygen use
Time frame: at Day 1 to Day 28
Duration of new oxygen use
Time frame: at Day 90
Duration of new ventilator or ECMO use
Time frame: at Day 1 to Day 28
Duration of new ventilator or ECMO use
Time frame: at Day 90
Number of non-invasive ventilation/high flow oxygen free days
Time frame: at Day 1 to Day 28
Number of non-invasive ventilation/high flow oxygen free days
Time frame: at Day 90
Number of oxygenation free days
Time frame: at Day 1 to Day 28
Number of oxygenation free days
Time frame: at Day 90
Patient all-cause mortality
Time frame: at Day 14, Day 28 and Day 90
Cumulative incidence of any AE
Time frame: at Day 1 to Day 90
Cumulative incidence of Grade 3 and 4 AEs
Time frame: at Day 1 to Day 90
Cumulative incidence of SAEs
Time frame: at Day 1 to Day 90
Percentage of re-hospitalization
Time frame: Hospital discharge to D90 ±2d
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 11 May 2023.
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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.
Jean-Michel PAWLOTSKY, MD, PhD study director
Assistance Publique Hôpitaux de Paris (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alisporivir in people with SARS-CoV-2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 13 inclusion and 33 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 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in SARS-CoV-2 viral load in nasopharyngeal swabs (time frame: at Day 1 and Day 7). 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 11 May 2023.