Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a new drug shield lungs from COVID-19's worst damage?

NCT ID NCT04472728

Disease control Sponsor: Biophytis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether an experimental drug called BIO101 can prevent severe breathing problems in hospitalized adults with COVID-19 pneumonia. Participants receive either BIO101 or a placebo for 28 days, and researchers track who develops respiratory failure, needs high-flow oxygen, or dies. The goal is to see if activating a protective pathway in the body can reduce the most dangerous complications of the infection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BIO101 (also called Sarconeos), an experimental drug that activates the Mas receptor to protect the lungs from severe damage
What this could lead to
If successful, BIO101 could become a treatment to prevent respiratory failure and reduce the need for mechanical ventilation in hospitalized COVID-19 patients.
What could go wrong
This is an early-to-mid-stage trial with a modest number of participants, so results may not be conclusive. The drug could also cause side effects or fail to show a clear benefit over placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

238 people

The number who actually took part.

Started

Aug 2020

Finished

Jun 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age: 45 and older (in France: 55 and older) 2. 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. 3. Hospitalized, in observation or planned to be hospitalized due to COVID-19 infection symptoms with anticipated hospitalization duration \>=3 days a. Participants can be included even if treated with: oxygen supplementation, High-flow oxygen (HFO2), bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) 4. With evidence of pneumonia based on all of the following: 1. Clinical findings on a physical examination 2. Respiratory symptoms developed within the past 14 days 5. 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: 1. Tachypnea: ≥25 breaths per minute 2. Arterial oxygen saturation ≤92% 3. 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: 1. ALT and AST ≤ 5x upper limit of normal (ULN) 2. Gamma-glutamyl transferase (GGT) ≤ 5x ULN 3. 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 1. Have a negative urine pregnancy test at screening 2. 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 participants 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. 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) 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. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101 8. In France: * Non-affiliation to compulsory French social security scheme (beneficiary or right-holder) * Being under tutelage or legal guardianship

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for COVID-19 are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19 SARS-COV2

Contacts and locations

Locations

  • AZ-Sint Maarten

    Mechelen, 2800, Belgium

  • Abrazo Health

    Phoenix, Arizona, 85015, United States

  • Avenida Dr. Enéas de Carvalho Aguiar, 44 - Centro de Pesquisa Clínica Prof. Dr. Fúlvio Pileggi - Bloco 1 - 1º Andar

    São Paulo, 103.034, Brazil

  • Barnum Medical Research, Inc. 1029 Keyser Ave Suite H

    Natchitoches, Louisiana, 71457, United States

  • Beaumont Health

    Royal Oak, Michigan, 48073, United States

  • CHU CLU Namur (Saint-Elisabeth) Place Louise Godin

    Namur, 15 5000, Belgium

  • CHU Saint-Pierre

    Brussels, Belgium

  • Centre Hospitalier Argenteuil

    Argenteuil, France

  • Centre Hospitalier Départemental de Vendée

    La Roche-sur-Yon, France

  • Centre Hospitalier Rene Dubos

    Cergy-Pontoise, France

  • Centre Hospitalier Universitaire Bordeaux

    Bordeaux, France

  • FDI Clinical Research - San Juan City Hospital

    San Juan, 00927, Puerto Rico

  • Hospital Municipal de Barueri Dr. Francisco Moran

    Barueri, São Paulo, Brazil

  • Hospital Vera Cruz

    Belo Horizonte, Minas Gerais, Brazil

  • Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto

    São José do Rio Preto, São Paulo, Brazil

  • Hospital e Maternidade Celso Pierro - PUCCAMP

    Campinas, São Paulo, Brazil

  • Hôpital Pitié-Salpêtrière, 47 bd de l'Hôpital, 75013 Paris

    Paris, 75013, France

  • Santa Casa de Porto Alegre

    Porto Alegre, Rio Grande do Sul, Brazil

  • United Health Services Hospitals

    Johnson City, New York, 13903, United States

  • Unité ambulatoire Service de Pneumologie, Médecine Intensive et Réanimation (SPMIR) 47-83 Boulevard de l'Hôpital

    Paris, Paris Cedex 13, 75651, France

  • University of California, Irvine

    Irvine, California, 92697, United States

  • WellSpan Health

    York, Pennsylvania, 17403, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.