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A prospective, randomized, open-label, controlled clinical study to evaluate the preventive effect of hydroxychloroquine on close contacts after exposure to the Novel Coronavirus Pneumonia (COVID-19)

A prospective, randomized, open-label, controlled clinical study to evaluate the preventive effect of hydroxychloroquine on close contacts after exposure to the Novel Coronavirus Pneumonia (COVID-19)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029803
Enrollment
Unknown
Registered
2020-02-14
Start date
2020-02-20
Completion date
Unknown
Last updated
2020-02-25

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

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

A1:Hydroxychloroquine, small dose
A2:Hydroxychloroquine, high dose
B1:Abidol hydrochloride, small dose
B2:Abidol hydrochloride, high dose

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old <= age <= 60 years old when screening, not limited to men and women; 2. Who are in close contact with suspected cases, confirmed cases, and positive test of new coronavirus nucleic acid, and those who have not taken effective protection, that is, close contacts; 3. Study subjects are willing to be randomly assigned to any designated treatment group; 4. Must agree to not participate in another study of study drugs until day 24 of completion of the study. 5. Participants volunteered to participate in this study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. The physician decides that participating in the trial is not in the best interest of the patient, or does not meet any conditions for safe follow-up in the protocol; 2. People with heart disease such as cardiac block; 3. People with eye diseases such as retina and cornea; 4. Severe liver disease (such as Child Pugh score >= C or AST > 5 times the upper limit); 5. Pregnancy or breastfeeding, or a positive pregnancy test during the pre-dose check; 6. Patients with known severe renal insufficiency (estimated glomerular filtration rate <= 30mL / min / 1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.

Design outcomes

Primary

MeasureTime frame
Number of patients who have progressed to suspected or confirmed within 24 days of exposure to new coronavirus;

Secondary

MeasureTime frame
Clinical manifestations and severity of suspected or confirmed patients;Body temperature;Cough severity classification;Oxygenation index;Chest CT lesion size;Incidence of severe adverse drug reactions;Blood routine, CRP, SAA values;

Countries

China

Contacts

Public ContactZhan Zhang

Renmin Hospital of Wuhan University

doctorzhang2003@163.com+86 18062567610

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026