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Interferon
Multiple Anti-Coronavirus Therapies for COVID-19 (ACTCOVID19 Trial)
Phase 3
Waitlist Available
Led By Richard Whitlock, MD PhD
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 days post randomization
Awards & highlights
ACTCOVID19 Trial Summary
This trial is testing different therapies to see if they can reduce the severity of symptoms in people with COVID-19.
Who is the study for?
This trial is for adults over 30 with COVID-19 who are at high risk due to age, gender, obesity, chronic diseases or diabetes. They must be diagnosed within the past week and not severely ill (not ventilated for more than 72 hours). People can't join if they have advanced kidney/liver disease, are pregnant/breastfeeding, or have allergies to the drugs being tested.Check my eligibility
What is being tested?
The ACT trial is testing Aspirin, Interferon-Beta, Colchicine, and Rivaroxaban in patients with COVID-19 to see if these treatments can prevent the disease from getting worse. Patients will be randomly assigned to receive one of these medications.See study design
What are the potential side effects?
Possible side effects include bleeding risks with Aspirin and Rivaroxaban; liver damage from Colchicine; flu-like symptoms from Interferon-Beta. Each medication has its own set of potential side effects that could vary among individuals.
ACTCOVID19 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 45 days post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 days post randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Inpatient trial - Aspirin and Rivaroxaban vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, death or major thrombosis (MI, stroke, ALI, or PE)
Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or death
Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of the composite of hospitalization, death or major thrombosis (MI, stroke, ALI, or PE)
+1 moreSecondary outcome measures
Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT)
Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death
Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death
+1 moreACTCOVID19 Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: RivaroxabanExperimental Treatment1 Intervention
Inpatients Only:
2.5 mg twice daily for 28 days.
Group II: Interferon Beta [This arm is now closed to recruitment]Experimental Treatment1 Intervention
Inpatients Only:
0.25 mg by subcutaneous injection on days 1, 3, 5 & 7
Group III: ColchicineExperimental Treatment1 Intervention
Outpatients:
0.6 mg twice daily for 3 days, then 0.6 mg once daily for 25 days (total 28 days).
Inpatients:
1.2 mg followed by 0.6 mg 2 hours later, then 0.6 mg twice daily for 28 days.
(*Depending on availability, 0.6 mg tablets can be substituted by 0.5 mg tablets for a regimen in outpatients of 0.5 mg twice daily for 3 days, then 0.5 mg once daily for 25 days [total 28 days]; and in inpatients of 1.0 mg followed by 0.5 mg 2 hours later, then 0.5 mg twice daily for 28 days).
Group IV: Aspirin (ASA)Experimental Treatment1 Intervention
Outpatients:
75 to 100 mg once daily for 28 days.
Inpatients:
75 to 100 mg once daily for 28 days
Group V: Usual Care (Control)Active Control1 Intervention
Outpatients and Inpatients: No constraints for treating physicians on the therapies within the standard of care arm. All key co-interventions will be documented.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin
2014
Completed Phase 4
~55580
Rivaroxaban
2015
Completed Phase 4
~157350
Colchicine
2020
Completed Phase 4
~15330
Interferon-Beta
2012
Completed Phase 3
~6730
Find a Location
Who is running the clinical trial?
BayerIndustry Sponsor
2,239 Previous Clinical Trials
25,326,061 Total Patients Enrolled
Population Health Research InstituteLead Sponsor
155 Previous Clinical Trials
673,245 Total Patients Enrolled
Richard Whitlock, MD PhDPrincipal InvestigatorPopulation Health Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are at high risk if you are 70 years or older, male, obese, have chronic heart, lung, or kidney disease, have active cancer, or have diabetes.You are at least 30 years old.You were diagnosed with a condition or your symptoms got worse within the last 7 days (ideally 72 hours).You have severe kidney disease.You have a serious liver disease.You are allergic to colchicine or plan to use it during the study.You are allergic to aspirin (ASA).You have a high risk of bleeding while taking aspirin.If you are an outpatient and are at high risk because you are 70 years old or older, or if you are male, obese, have chronic heart, lung, or kidney problems, are currently being treated for cancer, or have diabetes.Your kidneys are not working well, and your doctor estimates that your kidney function is very low.You are currently taking or planning to take certain blood thinners or antiplatelet medications.You are currently taking or planning to take strong inhibitors of CYP 3A4 and P-gp, like lopinavir/ritonavir, carbamazepine, or ketoconazole, with rivaroxaban.You have symptoms and have tested positive for COVID-19.You must be at least 30 years old to participate in the trial as an outpatient.You have symptoms and lab tests that confirm you have COVID-19 while you are in the hospital.You are currently taking or planning to take certain medications like cyclosporine, verapamil, HIV protease inhibitor, azole antifungal, or macrolide antibiotic (except azithromycin) along with colchicine.You are currently taking or planning to take other medications that prevent blood from clotting.
Research Study Groups:
This trial has the following groups:- Group 1: Colchicine
- Group 2: Usual Care (Control)
- Group 3: Aspirin (ASA)
- Group 4: Rivaroxaban
- Group 5: Interferon Beta [This arm is now closed to recruitment]
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what do medical professionals most often prescribe Aspirin?
"Aspirin is a medication that can help patients with pain, myocardial infarction, catarrh, and behcet's syndrome."
Answered by AI
Is this research study being conducted at more than one hospital in town?
"Currently, there are 12 running clinical trial sites, which are located at Woodstock Hospital, Niagara Health System-St. Catharine's, CardiAI Inc., and 9 other locations."
Answered by AI
Are researchers still recruiting people to participate in this clinical trial?
"According to the latest update, this clinical trial is not recruiting patients. However, it is worth noting that there are 1154 trials for severe acute respiratory syndrome and 263 trials for Aspirin that are actively enrolling participants."
Answered by AI
What do Aspirin's FDA regulations currently permit?
"Our experts have determined that aspirin is safe to use, giving it a score of 3."
Answered by AI
Does Aspirin have a long history of being tested in clinical trials?
"There are presently 263 ongoing studies researching aspirin, 83 of which are in Phase 3 clinical trials. While a few of the studies related to aspirin are taking place in New Orleans, Louisiana, there are 4811 different locations running similar studies."
Answered by AI
What makes this research project different from other similar ones?
"As of right now, 263 different Aspirin clinical trials are taking place in 1606 cities located in 71 different countries. The first trial began back in 2002 and was completed in the same year after it reached Phase 3 in the drug approval process. In the 18 years since then, 815 additional studies have been completed."
Answered by AI
How many individuals are currently signed up for this experiment?
"Patients are not being actively recruited for this study at the present time. This trial was initially posted on 4/21/2020. The latest update to the study was on 10/20/2022. If you are interested in other studies, please note that there are 1154 clinical trials for severe acute respiratory syndrome and 263 trials for Aspirin that are actively recruiting patients."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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