BridgeMD
Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC)
EU CTIS ID: 2023-508105-24-00
What this study is testing
Among outpatients with recently diagnosed SARS-CoV-2 infection to compare the safety and efficacy of a single infusion of hyperimmune immunoglobulin (hIVIG) versus placebo, each given with standard of care (SOC), on clinical status after seven days. Two hypotheses will be tested to address this primary objective, which compares the primary endpoint among two study populations: 1) participants where a direct-acting antiviral (DAA) or other anti-SARS-CoV-2 agent was not prescribed as part of SOC treatment (stratum 1, see Section 6.1); and 2) all randomized participants (stratum 1 and stratum 2 combined). Stratum 2 is defined by prescribed treatments in SOC that include: DAA or other anti-SARS-CoV2 agents that are recommended for use by established national or international COVID-19 treatment guidelines. The hIVIG treatment will be considered superior to placebo if either of the two hypotheses are rejected.
- 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
- Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an immunosuppressed condition.
- Positive test for SARS-CoV-2 within ≤5 days (if >1 test, the first positive is within ≤5 days). Tests may include an institutional-based nucleic acid amplification test (NAAT), or any protocol-approved rapid test.
- Within ≤5 days from symptom onset, if symptomatic from current SARS-CoV-2 infection.
- Agrees to not participate in another clinical trial for the treatment or management of SARS-CoV-2 infection through Day 7, or until hospitalized or significant disease progression if prior to Day 7 (defined by ordinal category 4 or 5).
- Participant provides written informed consent prior to study procedures and understands and agrees to adhere to planned study procedures through Day 28.
You likely can't join if
- Asymptomatic and had prior symptoms from the current infection that have now resolved (for >24 hours).
- In the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.
- Asymptomatic and has received a vaccination for COVID-19 (≥1 dose).
- Undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes).
- Evidence of pneumonia and/or hypoxia due to COVID-19 (NOTE: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level).
- Prior receipt of immunoglobulin product or passive immune therapy for SARS-CoV-2 in the past 90 days (i.e., convalescent plasma, SARS-CoV-2 monoclonal antibodies, or any IVIG).
See the full eligibility criteria
- Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an immunosuppressed condition.
- Positive test for SARS-CoV-2 within ≤5 days (if >1 test, the first positive is within ≤5 days). Tests may include an institutional-based nucleic acid amplification test (NAAT), or any protocol-approved rapid test.
- Within ≤5 days from symptom onset, if symptomatic from current SARS-CoV-2 infection.
- Agrees to not participate in another clinical trial for the treatment or management of SARS-CoV-2 infection through Day 7, or until hospitalized or significant disease progression if prior to Day 7 (defined by ordinal category 4 or 5).
- Participant provides written informed consent prior to study procedures and understands and agrees to adhere to planned study procedures through Day 28.
- Asymptomatic and had prior symptoms from the current infection that have now resolved (for >24 hours).
- In the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.
- Asymptomatic and has received a vaccination for COVID-19 (≥1 dose).
- Undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes).
- Evidence of pneumonia and/or hypoxia due to COVID-19 (NOTE: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level).
- Prior receipt of immunoglobulin product or passive immune therapy for SARS-CoV-2 in the past 90 days (i.e., convalescent plasma, SARS-CoV-2 monoclonal antibodies, or any IVIG).
- Any of the following thrombotic or procoagulant conditions or disorders: • acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization. • prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin III, protein C, or protein S.
- History of hypersensitivity to blood, plasma or IVIG excipients.
- Known IgA deficiency or anti-IgA antibodies.
- Medical conditions for which receipt of a 300 mL volume of IV fluid from study treatment may pose specific risk to the patient (e.g., decompensated congestive heart failure).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Nigeria
- Mexico
- Japan
- Thailand
- Argentina
- United States
- Israel
- Ukraine
- Peru
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Nigeria; Mexico; Japan; Thailand; Argentina and 4 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.