Testing the Efficacy and Safety of BIO101, for the Prevention of Respiratory Deterioration, in Patients with COVID-19 Pneumonia (COVA study)

Phase 1

• Conditions: Confirmed infection with SARS-CoV-2 (COVID-19); MedDRA version: 20.0Level: HLTClassification code 10047465Term: Viral infections NECSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001498-63-GB
• Lead Sponsor: Biophytis S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-09
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 465

Inclusion Criteria

1. Age: 55 and older.
2. A confirmed diagnosis of COVID-19 infection, within the last 14 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.
3. Hospitalized, in observation or planned to be hospitalized due to COVID-19 infection symptoms with anticipated hospitalization duration >=3 days
4. With evidence of pneumonia based on all of the following:
a. Clinical findings on a physical examination
b. Respiratory symptoms developed within the past 7 days
5. With evidence of respiratory decompensation that started not more than 4 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff:
a. Tachypnea: =25 breaths per minute
b. Arterial oxygen saturation =92%, on Oxygen at at least 3L/min
c. 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
6. Without a significant deterioration in liver function tests:
a. ALT and AST = 5x upper limit of normal (ULN)
b. Gamma-glutamyl transferase (GGT) = 5x ULN
c. Total bilirubin = 5×ULN
7. Willing to participate and able to sign an informed consent form (ICF)
8. Female participants 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
a. Have a negative urine pregnancy test at screening
b. Be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose.
9. Male participants 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 participant 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.
10. 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;
11. For France only: Being affiliated with a European Social Security.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1. Not needing or not willing to remain in a healthcare facility during the entire study medication (i.e. while receiving study medication)
2. Moribund condition (death likely in days) or not expected to survive for >7 days – due to other and non-COVID-19 related conditions
3. Participant on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ECMO), or high-flow Oxygen*
4. Participant within 7 days of participating in other therapeutic clinical trial with angiotensin-converting-enzyme inhibitors (ACEi), angiotensin-receptor blockers (ARB) or recombinant ACE-2
5. Participant not able to take medications by mouth (as capsules or as a powder, mixed in water).
6. 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)
7. For participants receiving RAS pathway modulators (e.g., ACEi, ARB, or renin or aldosterone inhibitors): not on a stable regimen for at least 4 weeks prior to screening or regimen not expected to remain stable for the duration of the study.
8. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101
9. Renal disease requiring dialysis, or known renal insufficiency (eGFR=30 mL/min/1.73 m2, based on Cockroft & Gault formula)
10. In France:
o Non-affiliation to compulsory French social security scheme (beneficiary or right-holder)
o Being under tutelage or legal guardianship
* High-flow oxygen is defined as delivery of oxygen at a flow of =16 L/min.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified