Testing the Efficacy and Safety of BIO101 for the Prevention of Respiratory Deterioration in COVID-19 Patients

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Covid-19, SARS-CoV2

In brief

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 Phase 2 exploratory Proof of Concept (PoC) study to provide preliminary data on the activity, safety and tolerability of BIO101 in the target population. Part 2 is a phase 3 pivotal randomized study to provide further evidence of safety and efficacy of BIO101 after 28 days of double-blind dosing. BIO101 is the investigational new drug that activates the Mas receptor (MasR) through the protective arm of the Renin Angiotensin System (RAS).

Key facts

Study ID: NCT04472728
Run by: Biophytis
People needed: 238
Starts: 2020-08-26
Expected to finish: 2022-09-30
Last updated by the study team: 2023-05-15

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto — São José do Rio Preto, São Paulo, Brazil
Avenida Dr. Enéas de Carvalho Aguiar, 44 - Centro de Pesquisa Clínica Prof. Dr. Fúlvio Pileggi - Bloco 1 - 1º Andar — São Paulo, Brazil
Unité ambulatoire Service de Pneumologie, Médecine Intensive et Réanimation (SPMIR) 47-83 Boulevard de l'Hôpital — Paris, Paris Cedex 13, France
Centre Hospitalier Argenteuil — Argenteuil, France
Centre Hospitalier Universitaire Bordeaux — Bordeaux, France
Centre Hospitalier Rene Dubos — Cergy-Pontoise, France
Centre Hospitalier Départemental de Vendée — La Roche-sur-Yon, France
Hôpital Pitié-Salpêtrière, 47 bd de l'Hôpital, 75013 Paris — Paris, France
FDI Clinical Research - San Juan City Hospital — San Juan, Puerto Rico
Abrazo Health — Phoenix, Arizona, United States
University of California, Irvine — Irvine, California, United States
Barnum Medical Research, Inc. 1029 Keyser Ave Suite H — Natchitoches, Louisiana, United States
Beaumont Health — Royal Oak, Michigan, United States
United Health Services Hospitals — Johnson City, New York, United States
WellSpan Health — York, Pennsylvania, United States
CHU Saint-Pierre — Brussels, Belgium
AZ-Sint Maarten — Mechelen, Belgium
CHU CLU Namur (Saint-Elisabeth) Place Louise Godin — Namur, Belgium
Hospital Vera Cruz — Belo Horizonte, Minas Gerais, Brazil
Santa Casa de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
Hospital Municipal de Barueri Dr. Francisco Moran — Barueri, São Paulo, Brazil
Hospital e Maternidade Celso Pierro - PUCCAMP — Campinas, São Paulo, Brazil

Full record on ClinicalTrials.gov

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