Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 20923 | Other Identifier | OGITT-INS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether hydroxychloroquine is an effective prophylactic regimen to prevent SARS-CoV-2 infection among healthcare workers. Participants will be randomized into two parallel groups. The first arm will evaluate the use of hydroxychloroquine every-other-day plus standard measures of protection for the prevention of SARS-CoV-2. The second arm will evaluate the use of standard measures of protection for the prevention of SARS-CoV-2. The target enrollment is 320 participants. Each study participant will be monitored for SARS-CoV-2 seroconversion in weekly visits or for the development of COVID-19 symptoms for 8 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine | Experimental | Hydroxychloroquine prophylaxis plus standard measures of personal protection. |
|
| Control | No Intervention | Standard measures of personal protection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | A loading dose of 600mg of hydroxychloroquine orally on the first day, followed by 400mg of hydroxychloroquine orally every-other-day and use of standard measures of personal protection provided from the hospital for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2 | Eight weeks | |
| Safety: Proportion of participants with grade 3 or more adverse events | Eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability: Proportion of participants that discontinue prophylactic treatment due to grade 1 or 2 adverse events | Eight weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alejandro Llanos, MD, PhD | Universidad Peruana Cayetano Heredia | Principal Investigator |
| Eduardo Gotuzzo, MD | Universidad Peruana Cayetano Heredia | Study Chair |
| Max Grogl, PhD | U.S. Naval Medical Research Unit Six | Study Chair |
| Patricia GarcÃa, MD, MPH, PhD | Universidad Peruana Cayetano Heredia | Study Chair |
| Manuel Espinoza, MD | Instituto de Nacional de Salud | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Médico Naval "Cirujano Mayor Santiago Távara" | Callao | 07006 | Peru | |||
| Hospital Nacional Arzobispo Loayza |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36849996 | Derived | Llanos-Cuentas A, Schwalb A, Quintana JL, Delfin B, Alvarez F, Ugarte-Gil C, Guerra Gronerth RI, Lucchetti A, Grogl M, Gotuzzo E. Hydroxychloroquine to prevent SARS-CoV-2 infection among healthcare workers: early termination of a phase 3, randomised, open-label, controlled clinical trial. BMC Res Notes. 2023 Feb 28;16(1):22. doi: 10.1186/s13104-023-06281-7. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lima |
| 15082 |
| Peru |
| Hospital Cayetano Heredia | Lima | 15102 | Peru |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |