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It is a randomized controlled trial to assess the efficacy of Ivermectin in COVID-19. Patient recruited will be assigned to two groups one group will be given ivermectin with standard chloroquine regimen and the other group will be receiving chloroquine only. Out come will be recorded by documenting PCR reports at 48, 96 and 144 hours.
INTERVENTION It will be a randomized controlled trial which will be done on COVID-19 patients proven by PCR fulfilling the criteria (asymptomatic/mild to moderate severity). They will be divided into two groups after randomization. Group A will be administered Ivermectin single dose of 12grams along with Chloroquine as per existing hospital guidelines and group B will be given Chloroquine alone. Dose of Ivermectin to be repeated at 1 week if PCR stays negative. PCR will be done on alternate days (48, 96 and 144hours) and the duration at which the PCR becomes negative will be compared. Dose of drug subject to change in accordance with patient response or possible side effect.
ELIGIBILITY CRITERIA INCLUSION CRITERIA
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 15 to 65 years In good general health with no or mild symptoms of Corona virus disease PCR positive for SARS-Cov-2. Ability to take oral medication and be willing to adhere to the drug intake regimen EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:
Severe symptoms likely attributed to Cytokine Release Storm. Malignant diseases, diabetes mellitus, chronic kidney disease and cirrhosis liver with CPT class B or C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin arm | Active Comparator | Participants will be administered Ivermectin with standard chloroquine regimen |
|
| Control arm | No Intervention | This arm will only receive chloroquine as per existing policy of hospital |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin 6 MG Oral Tablet (2 tablets) | Drug | 12 mg single dose of Ivermectin will be given to intervention arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Negative PCR | PCR will be done at 48, 96 and 144 hours | 144 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Need for mechanical ventilation | All patients will be assessed for requirement of mechanical ventilation in both the groups | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asma Asghar, FCPS MED | Contact | 00923225141033 | Asghar.asma79@gmail.com | |
| Najma Parveen, FCPS med | Contact | 00 92 322 5335786 |
| Name | Affiliation | Role |
|---|---|---|
| Karamat Hu Bukhari, FCPS MED | Combined military hospital lahore | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combined Military Hospital Lahore | Recruiting | Lahore | Punjab Province | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32251768 | Background | Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3. | |
| 32293834 | Result | Simsek Yavuz S, Unal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619. doi: 10.3906/sag-2004-145. |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| D004304 |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |