PRophylaxis of Exposed COVID-19 Individuals With Mild Symptoms Using choloroquinE Compounds

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04351191

Acronym

PRECISE

Enrollment

137

Registered

2020-04-17

Start date

2020-04-15

Completion date

2020-08-30

Last updated

2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19, Sars-CoV2, Symptomatic Condition

Brief summary

To treat Pakistani patients with non-life threatening symptomatic SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different chloroquine and hydroxychloroquine dosing regimens in controlling SARS-CoV-2 infection.

Interventions

DRUGHydroxychloroquine Sulfate Regular dose

Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2

DRUGHydroxychloroquine Sulfate Loading Dose

Hydroxychloroquine administered as a loading dose only

DRUGChloroquine

Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2

DRUGPlacebo

Standard of Care plus placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Prospective double blind randomized superiority clinical trial.

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Inclusion criteria

1. Symptomatic patients: defined as fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate \>22 per minute). 2. Nasopharyngeal RT-PCR positive SARS-CoV-2 3. Age 20-50 years 4. BMI 18-28 kg/m2 5. Informed consent

Exclusion criteria

1. O2 saturation by pulse-oximeter below 93% 2. Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes 3. Arrhythmias and/or history of arrythmia 4. Psoriasis and/or history of psoriasis 5. Neuropathy or myopathy and/or history of these 6. Hypoglycemia and/or history of hypoglycemia 7. Pre-existing hepatic disease 8. Pre-existing renal disease 9. Use of antacids within 1 week 10. Use of antiobiotics within 1 week 11. Pregnancy 12. RT-PCR performed \>7 days prior to enrollment

Design outcomes

Primary

Measure	Time frame	Description
RT-PCR result	6th and 7th day	Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7

Secondary

Measure	Time frame	Description
Progression of symptoms	7 days	Time to progression to next stage of SARS-CoV-2 disease severity index
Mortality	30 days	Death

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026