PRophylaxis of Exposed COVID-19 Individuals With Mild Symptoms Using choloroquinE Compounds (PRECISE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04351191 |
Recruitment Status :
Terminated
(Poor accrual)
First Posted : April 17, 2020
Last Update Posted : March 10, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sars-CoV2 Symptomatic Condition Covid-19 | Drug: Hydroxychloroquine Sulfate Regular dose Drug: Hydroxychloroquine Sulfate Loading Dose Drug: Chloroquine Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 137 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Prospective double blind randomized superiority clinical trial. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Symptomatic RT-PCR Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate |
Actual Study Start Date : | April 15, 2020 |
Actual Primary Completion Date : | August 23, 2020 |
Actual Study Completion Date : | August 30, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: HCQ Regular dose
Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care
|
Drug: Hydroxychloroquine Sulfate Regular dose
Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2 |
Experimental: HCQ Loading dose
Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care
|
Drug: Hydroxychloroquine Sulfate Loading Dose
Hydroxychloroquine administered as a loading dose only |
Active Comparator: CQ regular dose
Cholorquine 500 mg BID for 5 days plus standard of care
|
Drug: Chloroquine
Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2 |
Placebo Comparator: Placebo
Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)
|
Drug: Placebo
Standard of Care plus placebo |
- RT-PCR result [ Time Frame: 6th and 7th day ]Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7
- Progression of symptoms [ Time Frame: 7 days ]Time to progression to next stage of SARS-CoV-2 disease severity index
- Mortality [ Time Frame: 30 days ]Death

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Symptomatic patients: defined as fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).
- Nasopharyngeal RT-PCR positive SARS-CoV-2
- Age 20-50 years
- BMI 18-28 kg/m2
- Informed consent
Exclusion Criteria:
- O2 saturation by pulse-oximeter below 93%
- Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
- Arrhythmias and/or history of arrythmia
- Psoriasis and/or history of psoriasis
- Neuropathy or myopathy and/or history of these
- Hypoglycemia and/or history of hypoglycemia
- Pre-existing hepatic disease
- Pre-existing renal disease
- Use of antacids within 1 week
- Use of antiobiotics within 1 week
- Pregnancy
- RT-PCR performed >7 days prior to enrollment

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): NCT04351191
Pakistan | |
Expo Covid Isolation Center / Mayo Hospital Field Hospital | |
Lahore, Punjab, Pakistan | |
Mayo Hospital / King Edward Medical University | |
Lahore, Punjab, Pakistan | |
Pakistan Kidney and Liver Institute | |
Lahore, Punjab, Pakistan | |
Services Hospital | |
Lahore, Punjab, Pakistan |
Principal Investigator: | Ammar Sarwar, MD | Beth Israel Deaconess Medical Center |
Responsible Party: | Ammar Sarwar, Assistant Professor, Harvard Medical School, Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT04351191 |
Other Study ID Numbers: |
NBC-COVID1902 |
First Posted: | April 17, 2020 Key Record Dates |
Last Update Posted: | March 10, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases |
Respiratory Tract Diseases Hydroxychloroquine Chloroquine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents Amebicides |