BridgeMD
A study to evaluate the efficacy and safety of Bemnifosbuvir in High-Risk Outpatients with COVID-19
EU CTIS ID: 2023-504540-33-00
What this study is testing
To evaluate the efficacy of BEM compared with placebo in reducing all-cause hospitalization or all-cause death in COVID-19 outpatients receiving only supportive care.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Willing and able to provide informed consent.
- Positive SARS-CoV-2 diagnostic test (RT-PCR or validated rapid antigen test) conducted ≤ 5 days prior to randomization. Note: The test may be obtained locally. A documented historical record of positive result (RT-PCR or validated rapid antigen test) from test conducted ≤ 5 days prior to randomization is acceptable.
- Mild or moderate COVID-19 with symptom onset ≤ 5 days before randomization and at least one COVID-19 related symptom present at time of screening: • Mild COVID-19: - Symptoms of mild illness with COVID-19, which could include fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, and loss of taste or smell, without shortness of breath or dyspnea - No clinical signs indicative of moderate, severe, or critical illness severity • Moderate COVID-19: - Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion - Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, heart rate ≥ 90 beats per minute; with saturation of oxygen (SpO2) > 93% on room air -No clinical signs indicative of severe or critical illness severity
- For females of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 30 days after the final dose of study drug.
- Females of childbearing potential must have a negative pregnancy test prior to initiation of study drug.
- Subject must be able to take oral tablet medications.
You likely can't join if
- Female subject is pregnant or breastfeeding.
- History of severe hepatic impairment (Child-Pugh Class C)
- Known allergy or hypersensitivity to components of study drug.
- Malabsorption syndrome or other condition that would interfere with enteral absorption.
- Any clinically significant medical condition or known laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the subject or impact subject compliance or safety/efficacy observations in the study.
- Clinical signs or symptoms indicative of severe or critical COVID-19 illness, including any of the following: shortness of breath at rest, respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 beats per minute, SpO2 ≤ 93% on room air, partial pressure of oxygen/ fraction of inspired oxygen (PaO2/FiO2) <300, shock (defined by systolic blood pressure < 90 mm Hg or diastolic blood pressure < 60 mm Hg or requiring vasopressors), multi-organ dysfunction/failure, respiratory distress, respiratory failure; requirement of endotracheal intubation, mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO).
See the full eligibility criteria
Who can join
- Willing and able to provide informed consent.
- Positive SARS-CoV-2 diagnostic test (RT-PCR or validated rapid antigen test) conducted ≤ 5 days prior to randomization. Note: The test may be obtained locally. A documented historical record of positive result (RT-PCR or validated rapid antigen test) from test conducted ≤ 5 days prior to randomization is acceptable.
- Mild or moderate COVID-19 with symptom onset ≤ 5 days before randomization and at least one COVID-19 related symptom present at time of screening: • Mild COVID-19: - Symptoms of mild illness with COVID-19, which could include fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, and loss of taste or smell, without shortness of breath or dyspnea - No clinical signs indicative of moderate, severe, or critical illness severity • Moderate COVID-19: - Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion - Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, heart rate ≥ 90 beats per minute; with saturation of oxygen (SpO2) > 93% on room air -No clinical signs indicative of severe or critical illness severity
- For females of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 30 days after the final dose of study drug.
- Females of childbearing potential must have a negative pregnancy test prior to initiation of study drug.
- Subject must be able to take oral tablet medications.
- Subject is, in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study requirements.
- Subject must be high risk, defined below. • Age ≥70 years OR • Age ≥55 years with one of the following risk factors: -Obesity (body mass index [BMI] ≥30 kg/m2) -Diabetes mellitus -Cardiovascular disease (including congenital heart disease) or hypertension (with at least one medication recommended or prescribed) -Chronic lung disease requiring routine therapy (e.g., chronic obstructive pulmonary disease [COPD], moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension) OR • Age 50 to 54 inclusive with two of the following risk factors: -Obesity (body mass index [BMI] ≥30 kg/m2) -Diabetes mellitus -Cardiovascular disease (including congenital heart disease) or hypertension (with at least one medication recommended or prescribed) -Chronic lung disease requiring routine therapy (e.g., chronic obstructive pulmonary disease [COPD], moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension) OR • Age ≥18 years with one of the following: -Down syndrome -Sickle cell disease -Dementia -Parkinson's disease, -Care home residents -One of the following immunocompromising conditions or immunosuppressive treatments: --On immunosuppressive regimens including chemotherapy for the treatment of cancer --Hematologic malignancy associated with poor response to COVID-19 vaccines (e.g., CLL, non-Hodgkin lymphoma, multiple myeloma, acute leukemia) --Being within 2 years of a hematopoietic stem cell transplant --Receipt of a solid-organ transplant and on immunosuppressive therapy --Human immunodeficiency virus (HIV) infection (untreated) or with CD4+ T lymphocyte count <350 cells per cubic millimeter (mm3) --Moderate or severe primary immunodeficiency disorder --Active treatment with an immunosuppressive medication regimen (e.g., high-dose corticosteroids [ie, 20 mg of prednisone daily or equivalent for ≥2 weeks], alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents that are severely immunosuppressive, anti-tumor necrosis factor (TNF) blockers, biologics that are immunosuppressive) • Enrollment of high-risk adolescents (≥ 12 years to 17 years) will be allowed after the planned, pre-specified interim analysis for which 65% of the supportive-care-only stratum completed the follow-up period (Day 29). A DSMB recommendation that the study continue at this interim analysis point will trigger enrollment of adolescents.
What rules you out
- Female subject is pregnant or breastfeeding.
- History of severe hepatic impairment (Child-Pugh Class C)
- Known allergy or hypersensitivity to components of study drug.
- Malabsorption syndrome or other condition that would interfere with enteral absorption.
- Any clinically significant medical condition or known laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the subject or impact subject compliance or safety/efficacy observations in the study.
- Clinical signs or symptoms indicative of severe or critical COVID-19 illness, including any of the following: shortness of breath at rest, respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 beats per minute, SpO2 ≤ 93% on room air, partial pressure of oxygen/ fraction of inspired oxygen (PaO2/FiO2) <300, shock (defined by systolic blood pressure < 90 mm Hg or diastolic blood pressure < 60 mm Hg or requiring vasopressors), multi-organ dysfunction/failure, respiratory distress, respiratory failure; requirement of endotracheal intubation, mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO).
- Admitted to a hospital within 90 days prior to randomization due to COVID-19 or is hospitalized (inpatient) for any reason at randomization. Note: If local policy requires COVID-19 isolation or internment in a hospital or similar facility, but subjects otherwise meet inclusion criteria, this exclusion may not apply. However, subjects under clinical observation at a clinic/study site or hospital with plans to remain in that setting overnight are not study eligible.
- In the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization within 24 hours.
- Use of other investigational drugs within 30 days prior to planned dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study, except for unblinded protocols that don't include direct acting antivirals for COVID-19 (e.g., open-label oncological regimen variations or biologic studies). Note: Prior to enrolling subjects that are on other open-label studies, it is the site's responsibility to ensure that the study criteria for that study allow for enrollment into this study.
- Initiation or planned initiation of remdesivir for treatment of the current SARS-CoV-2 infection.
- Requirement of any prohibited medications, as described in Section 5.7 of protocol, including either hydroxychloroquine or amiodarone within 3 months prior to screening. Note: Subjects who had already initiated any COVID-19 drug with antiviral effects intended to treat symptomatic SARS-CoV-2 infection (≥ 24 hours prior to randomization) will be excluded. During screening (or within 24 hours prior to or after randomization), locally available COVID-19 drugs with antiviral effects (including but not limited to nirmatrelvir/ritonavir, molnupiravir, favipiravir, mAbs) will be permitted
- Other known active viral or bacterial infection at the time of screening, such as influenza (i.e., as verified by a locally available rapid flu test at screening) or respiratory syncytial virus (RSV). Note: This exclusion does not apply to subjects with stable chronic viral infections, such as chronic HCV or HIV providing other eligibility criteria are met.
- Receiving dialysis or have severe renal impairment [i.e. estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula]. Note: If the investigator suspects the subject may have eGFR <30 mL/min/1.73 m2, a confirmatory test should be performed at screening to confirm eligibility before the first dose of study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Saudi Arabia
- Thailand
- Philippines
- Japan
- Kenya
- Ghana
- India
- Canada
- Egypt
- Brazil
- Mexico
- Morocco
- Turkey
- United Kingdom
- Argentina
- Pakistan
- South Africa
- Colombia
- Chile
- Tunisia
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saudi Arabia; Thailand; Philippines; Japan; Kenya; Ghana and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.