|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT04523831 |
|
Date of registration:
|
19/08/2020 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Clinical Trial of Ivermectin Plus Doxycycline for the Treatment of Confirmed Covid-19 Infection
|
|
Scientific title:
|
A Phase III Trial to Promote Recovery From Covid 19 With Combined Doxycycline and Ivermectin Along Standard Care |
|
Date of first enrolment:
|
June 1, 2020 |
|
Target sample size:
|
400 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT04523831 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Bangladesh
| | | | | | | |
|
Contacts
|
|
Name:
|
Mahmud Reaz, FCPS |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Assistant Professor |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- COVID-19 infection, confirmed by polymerase chain reaction (PCR) test within 3 days
from enrollment
- Only mild and moderate COVID-19 infected cases
- Able to provide informed consent
Exclusion Criteria:
- Unable to take oral medication
- Pregnant or breast feeding lady
- Patients with severe COVID symptoms or admission in ICU/HDU
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) more than 5 upper
limit of normal (ULN)
- On non-invasive positive pressure ventilation or mechanical ventilation at time of
study entry
- Known hypersensitivity to Doxycycline or ivermectin or its components.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Covid19
|
|
Intervention(s)
|
|
Drug: Standard of care
|
|
Drug: Ivermectin and Doxycycline
|
|
Primary Outcome(s)
|
|
Number of Patients With Early Clinical Improvement
[Time Frame: 7 days]
|
|
Number of Participants With Late Clinical Recovery
[Time Frame: 12 days]
|
|
Secondary Outcome(s)
|
|
Number of Patients Remain Persistently Positive for RT-PCR of Covid-19
[Time Frame: 14 days]
|
|
Number of Patients Having Clinical Deterioration.
[Time Frame: 1 month]
|
|
Secondary ID(s)
|
|
ERC-DMC/ECC/2020/117
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|