Testing the Efficacy and Safety of BIO101 for the Prevention of Respiratory Deterioration in COVID-19 Patients (COVA)
Covid-19, SARS-CoV2
About this trial
This is an interventional treatment trial for Covid-19
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Abrazo Health
- University of California, Irvine
- Barnum Medical Research, Inc. 1029 Keyser Ave Suite H
- Beaumont Health
- United Health Services Hospitals
- WellSpan Health
- CHU Saint-Pierre
- CHU Saint-Pierre
- AZ-Sint Maarten
- CHU CLU Namur (Saint-Elisabeth) Place Louise Godin
- Hospital Vera Cruz
- Santa Casa de Porto Alegre
- Hospital Municipal de Barueri Dr. Francisco Moran
- Hospital e Maternidade Celso Pierro - PUCCAMP
- Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
- Avenida Dr. Enéas de Carvalho Aguiar, 44 - Centro de Pesquisa Clínica Prof. Dr. Fúlvio Pileggi - Bloco 1 - 1º Andar
- Unité ambulatoire Service de Pneumologie, Médecine Intensive et Réanimation (SPMIR) 47-83 Boulevard de l'Hôpital
- Centre Hospitalier Argenteuil
- Centre Hospitalier Universitaire Bordeaux
- Centre Hospitalier Rene Dubos
- Centre Hospitalier Départemental de Vendée
- Hôpital Pitié-Salpêtrière, 47 bd de l'Hôpital, 75013 Paris
- FDI Clinical Research - San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
BIO101
Placebo
BIO101 350 mg bid
Placebo