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Hydroxychloroquine in COVID-19 Patients

Use of Hydroxychloroquine in Patients With COVID-19: A Randomized Controlled Clinical Trial

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04394442
Enrollment
200
Registered
2020-05-19
Start date
2020-03-21
Completion date
2020-08-31
Last updated
2020-05-19

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

Conditions

COVID-19

Brief summary

Many reports argued about the possible beneficial effects of Hydroxychloroquine in treating COVID-19 patients and this study was designed to investigate this claim

Interventions

DRUGHydroxychloroquine

400mg BD first day then 200 mg BD for 5 days

Sponsors

Samah Lutfy
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Confirmed cases of SARS-CoV-2 by PCR

Exclusion criteria

less than 18 years old known hypersensitivity to the drug

Design outcomes

Primary

MeasureTime frameDescription
time to viral clearance21 days after patients randomizationPCR will be done every 72 h day till 2 consecutive negative PCR tests(24h apart) which is the viral clearance.The time between randomization and viral clearance is the viral clearance time
% of mortality60 days after randomizationtotal number of deaths divided by total number of the group

Secondary

MeasureTime frameDescription
Length of stay60 days after randomizationtime from patients randomization till discharge
time to be afebrile60 days after randomizationtime from randomization till day of fever subsiding
need for mechanical ventilation60 days after randomization%of deteriorated patients necessitates mechanical ventilation

Countries

Saudi Arabia

Contacts

Primary ContactSamah M Lutfy, MD
omar1star2008@yahoo.com+966581244415

Outcome results

None listed

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