WHAT ARE ACTIV CLINICAL TRIALS FOR COVID-19?
In April 2020, the National Institutes of Health (NIH) launched the public-private partnership, Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV). ACTIV’s goal is to discover safe and effective treatments and vaccines for COVID-19. Your COVID-19 positive patient may be eligible to join an ACTIV clinical trial if they:
- Have mild to moderate symptoms of COVID-19, but have not been hospitalized
- Are hospitalized with moderate to severe COVID-19 infection
- Were hospitalized due to COVID-19 and are now recovering at home
HEALTHCARE PROVIDERS’ ROLES IN ACTIV
ACTIV is led by healthcare professionals who have previously pioneered essential public health initiatives that have shaped our current guidelines for patient care. It is absolutely critical to continue fervent efforts in research as COVID-19 variants continue to emerge and the COVID-19 pandemic evolves. Healthcare providers are the leaders of the COVID-19 public health crisis and can help patients the most.
There are several hundred ACTIV clinical trial sites across the United States and in every region. This gives everyone more potential options for COVID-19 treatment and strengthens data validity across patient populations. Thousands of participants have already participated in ACTIV and continue to enroll every day.
STAGES OF COVID-19 IN ACTIV STUDIES
ACTIV has clinical trial options testing different treatments for each stage of COVID-19 based upon presenting symptoms, from mild to critical in severity, within inpatient and outpatient settings. Interested participants are pre-screened further to determine eligibility. Combat COVID continuously updates information for each ACTIV clinical trial arm as studies are launched and concluded by NIH.
INSIDE ACTIV CLINICAL TRIALS
Everyone who participates in ACTIV clinical trials receives the same standard of care as followed by NIH recommended guidelines for treatment of COVID-19, regardless of clinical trial enrollment. Participants could receive the investigational therapy or the placebo (control group), depending upon their randomization assignment.
Researchers monitor all participants for safety during and after the clinical trial period with assessments in person and potentially by telephone or virtually. Just as enrollment in any clinical trial is a choice, participants may choose to discontinue enrollment at any time. Clinical researchers advocate for continuity in patient care and encourage all participants to continue their healthcare journey with their original trusted healthcare providers upon clinical trial conclusion.
THERAPEUTICS BEING INVESTIGATED
ACTIV clinical trials are seeking further treatments and prevention for COVID-19, which includes testing classes of therapies that have been successfully used to treat other conditions and are now being considered for potential COVID-19 remedies. Monoclonal antibodies (mAbs), antivirals, and antithrombotics are some of the classes already being tested. However, medications that can be self-administered orally or by inhalation are part of an initiative to find an easier, more accessible option for COVID-19 patients to reduce symptoms.
INSIDE ACTIV CLINICAL TRIALS
ACTIV is currently recruiting for the following clinical trials:
ACTIV-1: Immune Modulators (IM)
Eligible participants include adults who are already in the hospital, including patients in the emergency room waiting to be admitted to the hospital, and patients in or leaving intensive care and who have moderate to severe COVID-19 infection.
ACTIV-2: Outpatient mAbs and Other Therapies
Eligible participants include adults who are not hospitalized with COVID-19 and who are experiencing mild to moderate symptoms within 8 days of enrolling, and who have tested positive for COVID-19 within 10 days of enrollment.
Participants in ACTIV-2 who qualify as at risk for severe COVID-19 infection may be eligible to enroll in a clinical trial to test a mAb combination with the aim of reducing the chances of being hospitalized and recovering faster from COVID-19.
ACTIV-3: Therapeutics for Inpatients with COVID-19 (TICO)
Eligible participants include adults who are hospitalized with COVID-19 infection and have had symptoms for 12 days or less.
Eligible participants include adults who have not been hospitalized, those who are currently hospitalized, and those discharged after hospitalization for moderate to severe COVID-19 infection.
ACTIV-5: Big Effect Trial
Eligible participants include adults who are hospitalized with COVID-19 infection.
Eligible participants include adults who are at least 30 years old, have been diagnosed with COVID-19, are experiencing at least two symptoms, and are not in the hospital.
Other ACTIV-associated clinical trials are also seeking participants. These are also NIH-sponsored clinical trials for additional testing of COVID-19 treatments.
HOW HEALTHCARE PROVIDERS CAN HELP PATIENTS ENROLL IN ACTIV
Visit the Combat COVID website to learn more about ACTIV clinical trial opportunities and other essential COVID-19 education for your patients.
Educational toolkits are also available for you to download and give to your healthcare staff and patients. You can also contact Combat COVID’s call center at 1-877-414-8106 and speak with an information specialist about clinical trials near you.