FAQS: CLINICAL TRIALS FOR COVID-19
Participants are assigned to one or more therapeutic interventions (which may include a placebo or other control) to evaluate the safety and efficacy of a particular treatment. Clinical trials help discover new or better ways to prevent, treat, or cure disease.
ACTIV clinical trials use an innovative adaptive platform trial design to test multiple therapies simultaneously and quickly remove treatments that have been proven less effective.
No, a formal referral is not required for ACTIV clinical trial participation. However, you can connect your patient to valuable resources on Combat COVID to help them consider options for COVID-19 clinical trials.
Participants are carefully pre-screened to determine safe eligibility. The principal investigator (PI) manages and assesses all participants’ care throughout the clinical trial. Safety and efficacy of therapeutic interventions are monitored during and after completion of participation.
As with any clinical trial or therapy administered, there can be potential risks and benefits involved. These are specific to each clinical trial and are reviewed during the consent process with participants. However, COVID-19 patients could have access to more treatment options sooner through clinical trials. Visit the Combat COVID Clinical Trials page to review available clinical trial options or call 1-877-414-8106 to speak to a live medical information specialist about you or your patient’s ACTIV trial questions.
Participants can request to have any eligible records from a clinical trial sent to their primary healthcare provider for continuity of care. Personal health information is confidential, and any eligible records will not be shared unless a participant completes a medical records request.
Participants are instructed to report any side effects or symptoms experienced during or after a clinical trial to the PI or research site. The PI will report all adverse events (suspected or unexpected) to the study sponsor and the U.S. Food and Drug Administration.
Your patient will be asked to continue their care with their primary and specialty healthcare providers in collaboration with the research team. If your patient is considering ACTIV clinical trial participation, it is essential to contact any potential clinical trials before prescribing any treatments for COVID-19. All prescribed therapies for managed chronic conditions will be continued, unless contraindicated.
IMPORTANCE OF COVID-19 CLINICAL TRIALS: WHY SHOULD PATIENTS PARTICIPATE?
ACTIV clinical trials for COVID-19 may help us to:
Note: Patients are only eligible for monoclonal antibody treatment within 10 days of testing positive for COVID-19.
- Provide potential treatment options for patients who have not received the COVID-19 vaccine.
- Reduce symptom severity and decrease the risk for severe outcomes or deaths.
- Find symptom alleviation for recovered COVID-19 patients who are experiencing long-term effects from COVID-19.
- Explore more accessible, feasible COVID-19 treatment and prevention options for all patient populations.
- Continue efforts to combat emerging variants of COVID-19.
- Expand the timeframe of delivery for COVID-19 treatment options.
FAQS: CLINICAL TRIALS FOR COVID-19 TREATMENTS
Participants can decide to exit a clinical trial at any time for any reason. If they discontinue enrollment before the study ends, a medical team will continue to monitor them and complete follow ups to ensure safety and continuity of care.
Clinical trial participation is offered at no cost to the patient through the site sponsor and government funding and is not financed through insurance. Patients who enroll in a clinical trial will not receive a bill for their participation.
YOUR ROLE AS A HEALTHCARE PROVIDER
Learn about ACTIV clinical trials and help COVID-19 patients explore available clinical trial options at CombatCOVID.hhs.gov or call the ACTIV trial call center at 1-877-414-8106. Scientists and organizations can also make submissions for vaccines and therapeutic ideas for COVID-19 through the National Institutes of Health COVID-19 Candidate and Technologies Portal.
Yes! Information about the ACTIV trials is available in Spanish at https://CombateCOVID.hhs.gov. Spanish-speaking information specialists are also available to answer questions about the ACTIV trials at 1-877-414-8106.