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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-15

Study Completion Date

2020-08-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Sars-CoV2 Symptomatic Condition Covid-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective double blind randomized superiority clinical trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HCQ Regular dose

Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care

Group Type ACTIVE_COMPARATOR

Hydroxychloroquine Sulfate Regular dose

Intervention Type DRUG

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

HCQ Loading dose

Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care

Group Type EXPERIMENTAL

Hydroxychloroquine Sulfate Loading Dose

Intervention Type DRUG

Hydroxychloroquine administered as a loading dose only

CQ regular dose

Cholorquine 500 mg BID for 5 days plus standard of care

Group Type ACTIVE_COMPARATOR

Chloroquine

Intervention Type DRUG

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

Placebo

Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Standard of Care plus placebo

Interventions

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Hydroxychloroquine Sulfate Regular dose

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

Intervention Type DRUG

Hydroxychloroquine Sulfate Loading Dose

Hydroxychloroquine administered as a loading dose only

Intervention Type DRUG

Chloroquine

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

Intervention Type DRUG

Placebo

Standard of Care plus placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No