SARS-CoV2 Infection Clinical Trial
Official title:
Comparative Efficacy of Ivermectin Versus Combination of Hydroxychloroquine Plus Darunavir/ Ritonavir for Shortening Duration of SARS-CoV2 Detection From Respiratory Secretion Among Asymptomatic or Afebrile COVID-19 Infection
This is an open label randomised controlled study of oral ivermectin (600 mcg/kg/d* 3 day) versus combined of hydroxychloroquine plus darunavir/ ritonavir for 5 days treatment among asymptomatic carrier of SAR-CoV2 adult Thai population. Both study treatment regimens will have oral zinc sulfate combination treatment ( 200mg. twice daily). Outcomes include safety and duration of detectable of SAR-CoV2 in nasopharyngeal/ throat (NP) swab by polymerase chain reaction amplification (PCR) after treatment. 40-50 patients in each treatment arm is planned, with an interim analysis when approximately 50% of cases is enrolled.
- Study procedure will be carried out after informed consent is obtained. - Baseline physical exam and laboratory investigations will be performed. - Eligible patients will be randomized to one of the two treatment arms. - Symptoms and signs will be monitored daily. - NP swab will be done at day5-7, and prior to discharge. - Complete blood counts, blood chemistries, electrocardiography will be performed for adverse event monitoring within 5 days after end of study drugs' administration. - Patients will be discharged at 2- 4 weeks after hospitalization, according to PCR results. - There will be 1-2 follow up visit at out patient clinic for NP swab (patients with +ve last NP swab before discharge), and blood tests. - Additional 5-8 ml. of EDTA blood will be taken at baseline and weekly for antibody detection. - Interim analysis of both safety and efficacy will be performed when approximately 50% of enrollment is achieved. - Intention to treat analysis is planned at the completion of enrollment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04979858 -
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
|
N/A | |
| Recruiting |
NCT05311410 -
Viral Kinetics of SARS-CoV-2 in Patients With COVID-19 in the Intensive Care Unit Undergoing Dental Procedures
|
N/A | |
| Active, not recruiting |
NCT05073718 -
SARS-CoV-2 and Acetylsalicylic Acid (SARA)
|
Phase 3 | |
| Completed |
NCT05060510 -
The School SPIT Study - COVID-19 Testing in Secondary Schools
|
N/A | |
| Completed |
NCT05055492 -
The School SPIT Study - Elementary Schools in High COVID-19 Incidence Regions
|
N/A | |
| Completed |
NCT05055505 -
The School SPIT Study - Elementary Schools in Low COVID-19 Incidence Regions
|
N/A | |
| Completed |
NCT05054218 -
COVID-19 Immunogenicity of a Third Dose of mRNA-1273 Vaccine Among Cancer Patients
|
||
| Completed |
NCT05449392 -
Topical Antibacterial Agents for Prevention of COVID-19
|
Phase 1 | |
| Completed |
NCT05076253 -
Efficacy of Ivermectin in COVID-19
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05172024 -
Understanding the Long-term Impact of COVID-19 in Adults (RECOVER)
|
||
| Terminated |
NCT05593770 -
International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response
|
Phase 2/Phase 3 | |
| Completed |
NCT05030974 -
RECOVAC Repeated Vaccination Study
|
Phase 4 | |
| Withdrawn |
NCT05067946 -
Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT05013034 -
Exploratory Regimen of Basiliximab for Treatment of Pulmonary Cytokine Storm in SARS-CoV-2 Hospitalized Adult Patients
|
Phase 2 | |
| Withdrawn |
NCT05393999 -
SABRE: A Single-arm Prospective Study Measuring Safety and Tolerability of SARS-CoV-2 Neutralising Antibodies in High-risk Populations
|
Phase 2 | |
| Recruiting |
NCT05047783 -
Masitinib in Patients With Symptomatic Mild to Moderate COVID-19
|
Phase 2 | |
| Not yet recruiting |
NCT05116657 -
Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome
|
||
| Recruiting |
NCT04590222 -
Impact of a Monoamine Oxidase Inhibitor on the Phenotype of Blood Mononucleated Cells in Patients With COVID-19
|
||
| Completed |
NCT04953039 -
Use of Saliva for COVID-19 Diagnosis
|
||
| Recruiting |
NCT04999098 -
Echinaforce COVID-19 Shedding Study
|
Phase 4 |