Contact Person From COVID-19 Confirmed Patient Clinical Trial
— COVID-19Official title:
A Study of Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)
| Verified date | August 2021 |
| Source | Gangnam Severance Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
There is no known definite treatment after exposure to SARS-CoV-2, but the some animal and clinical trials confirmed the efficacy of hydroxychloroquine (HCQ) or chloroquine against SARS-CoV-2. Thus, in this study, we aim to evaluate the efficacy and safety of hydroxychloroquine as post exposure prophylaxis for SARS-CoV-2. - Primary end point: comparison the rate of COVID-19 between PEP with HCQ and control group. - Secondary end point: Comparison of the rate of COVID-19 according to the contact level (time, place, degree of wearing personal protective equipment). - Safety comparison: Safety verification by identifying major side effects in the HCQ group."
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 29, 2020 |
| Est. primary completion date | June 29, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | Inclusion Criteria: - A contact person from confirmed case of SARS-CoV-2 infection - Medical staff exposed from confirmed case of SARS-CoV-2 infection in hospitals - Persons exposed to SARS-CoV-2 in COVID-19 outbreak situation with certain workplaces, religious groups, and military, etc. - Subjects of study include both symptomatic and asymptomatic contacts. Exclusion Criteria: - Hypersensitivity to Chloroquine or Hydroxychloroquine - Those who are contraindicated in Hydroxychloroquine administration according to the permission requirements such as pregnant women, nursing mothers, visual disorders, macular disease, and porphyria, etc. - Human immunodeficiency virus (HIV) infected person - Patients with autoimmune disease (Systemic lupus erythematosus, Mixed connective tissue disease) - Patients with autoimmune rheumatoid inflammatory disease (AIIRD; Autoimmune inflammatory rheumatic diseases - Ankylosing spondylitis, Rheumatic arthritis, Psoriatic arthritis) - Arrhythmia, liver cirrhosis of Child Pugh C, chronic renal failure with eGFR=30mL / min / 1.73m2 - A person who is positive in the COVID-19 screening PCR test before starting PEP |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Gangnam Severance Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Gangnam Severance Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The rate of COVID-19 | After postexposure prophylaxis, the rate of COVID-19 conversion between two groups | PCR test of COVID-19 at 14 days after the contact from confirmed case |