Asymptomatic COVID-19 Trial (ACT)
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|ClinicalTrials.gov Identifier: NCT04374552|
Recruitment Status : Withdrawn (The investigators have decided not to go forward with this protocol)
First Posted : May 5, 2020
Last Update Posted : November 2, 2020
The coronavirus disease-2019 (COVID-19) is spreading throughout the United States. While there are no known therapies to treat those who have become sick, there have been some reports that a medication currently used to treat rheumatoid arthritis, lupus, and malaria (Hydroxychloroquine sulfate, also known as Plaquenil) may help to lessen the chance or severity of illness, especially if combined with a medicine that treats other kinds of infections (Azithromycin, also known as Zithromax or Zmax or Zpak).
There are some people who test positive for the virus but who are otherwise not ill. Current standard of care is to advise these people to self-monitor but no treatment is offered. It is not known how many of these individuals will remain symptom free, and how many will become sick or how severe those symptoms will be. This study will randomize those people who do not have symptoms into one of three treatment plans 1) Hydroxycholoquine and Azithromycin, or 2) no active medication (placebo). All participants will be followed for 2 months.
The study will determine if there is any benefit to those who are asymptomatic to taking taking Hydroxychloroquine sulfate in combination with Azithromycin, or if there is no benefit from taking these medications.
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV-2 Infection||Drug: Hydroxychloroquine sulfate &Azithromycin Drug: Placebo||Phase 2|
Participants will be randomized into one of two treatment plans
- Hydroxycholoquine sulfate in combination with Azithromycin Hydroxycholorquine as above, plus Azithromycine: 500 mg po for day 1and then 250 mg QD for 4 days
- no active medication (placebo)
All participants will be followed for 2 months. The primary aim is to determine if there is any benefit (reduced likelihood for development of fever and other symptoms of COVID-19 ) to taking only Hydroxychloroquine sulfate, or to taking Hydroxychloroquine sulfate in combination with Azithromycin, or if there is no benefit to taking these medications for this population.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Study medication will be tablets containing either active drug or placebo|
|Official Title:||RCT in Asymptomatic Volunteers With COVID-19 Comparing Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone vs Standard of Care Without Antibiotics|
|Estimated Study Start Date :||May 5, 2020|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||April 2021|
Experimental: Hydroxychloroquine & Azithromycin
Hydroxychloroquine sulfate 400 mg po BID for day one and then 400 mg QD for 4 days Azithromycin 500 mg po on day one, followed by 250 mg po QD X 4 days
Drug: Hydroxychloroquine sulfate &Azithromycin
Drug - Hydroxychloroquine sulfate &Azithromycin
Placebo Comparator: Placebo
Placebo for Hydroxychloroquine sulfate (2 pills bid day one and then 2 tablets QD for 4 days) Placebo for Azithromycin (2 pills on day one and followed by 1 pill po QD x 4 days)
Drug - placebo
- The primary outcome is the rate of decline in viral load over the 10 days after randomization [ Time Frame: 10 days ]Change in SARS-CoV-2 viral from baseline to day 6
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374552
|United States, New Jersey|
|Robert Wood Johnson University Hospital|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Jeffrey L Carson, MD||Rutgers, The State University of New Jersey|