Status:
TERMINATED
Testing the Efficacy and Safety of BIO101 for the Prevention of Respiratory Deterioration in COVID-19 Patients
Lead Sponsor:
Biophytis
Conditions:
Covid-19
SARS-CoV2
Eligibility:
All Genders
45+ years
Phase:
PHASE2
PHASE3
Brief Summary
The COVA clinical study is a global multicentric, double-blind, placebo-controlled, group sequential and adaptive 2 parts phase 2-3 study targeting in patients with SARS-CoV-2 pneumonia. Part 1 is a P...
Detailed Description
Biophytis is developing BIO101, an investigational new drug, an oral preparation of immediate-release 20-hydroxyecdysone (20E) at ≥ 97% purity. BIO101 activates MasR on the protective arm of the Renin...
Eligibility Criteria
Inclusion
- Age: 45 and older (in France: 55 and older)
- A confirmed diagnosis of COVID-19 infection, within the last 28 days, prior to randomization, as determined by PCR or other approved commercial or public health assay, in a specimen as specified by the test used.
- Hospitalized, in observation or planned to be hospitalized due to COVID-19 infection symptoms with anticipated hospitalization duration \>=3 days
- a. Patients can be included even if treated with: oxygen supplementation, High-flow oxygen (HFO2), BiPAP and CPAP
- With evidence of pneumonia based on all of the following:
- Clinical findings on a physical examination
- Respiratory symptoms developed within the past 14 days
- With evidence of respiratory decompensation that started not more than 7 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff:
- Tachypnea: ≥25 breaths per minute
- Arterial oxygen saturation ≤92%
- A special note should be made if there is suspicion of COVID-19- related myocarditis or pericarditis, as the presence of these is a stratification criterion
- Without a significant deterioration in liver function tests:
- ALT and AST ≤ 5x upper limit of normal (ULN)
- Gamma-glutamyl transferase (GGT) ≤ 5x ULN
- Total bilirubin ≤ 5×ULN
- Willing to participate and able to sign an informed consent form (ICF)
- Female subjects should be:
- at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile; OR
- Have a negative urine pregnancy test at screening
- Be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose.
- Male subjects who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product; Note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy.
- Male subjects must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product;
- For France only: Being affiliated with a European Social Security.
Exclusion
- Not needing or not willing to remain in a healthcare facility during the entire study medication (i.e. while receiving study medication)
- Moribund condition (death likely in days) or not expected to survive for \>7 days - due to other and non-COVID-19 related conditions
- Patient on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ECMO)
- Patient within 7 days of participating in other therapeutic clinical trial with angiotensin-converting-enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB) or recombinant ACE-2
- Patient not able to take medications by mouth (as capsules or as a powder, mixed in water).
- Disallowed concomitant medication:
- a. Consumption of any herbal products containing 20-hydroxyecdysone and derived from Leuzea carthamoides; Cyanotis vaga or Cyanotis arachnoidea is not allowed (e.g. performance enhancing agents)
- Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101
- In France:
- Non-affiliation to compulsory French social security scheme (beneficiary or right-holder)
- Being under tutelage or legal guardianship
Key Trial Info
Start Date :
August 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT04472728
Start Date
August 26 2020
End Date
September 30 2022
Last Update
May 15 2023
Active Locations (22)
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1
Abrazo Health
Phoenix, Arizona, United States, 85015
2
University of California, Irvine
Irvine, California, United States, 92697
3
Barnum Medical Research, Inc. 1029 Keyser Ave Suite H
Natchitoches, Louisiana, United States, 71457
4
Beaumont Health
Royal Oak, Michigan, United States, 48073