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To measure the effect of Ivermectin (sub-cutaneous) with or without zinc in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.
This is a parallel assigned, randomized, controlled, multi-armed, investigator Initiated interventional study is designed to demonstrate efficacy to lower the viral load of COVID-19 and to demonstrate the antiviral effects of subcutaneous Ivermectin with or without zinc in mild to moderate symptomatic patients who consent to randomization following a new diagnosis in Pakistan with COVID-19 (PCR positive). Investigators will follow up with participants daily and PCR will be done on alternate days in BSL-3 lab. Dose will only be repeated if test remained positive..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin alone | Active Comparator | Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care |
|
| Ivermectin with Zinc | Active Comparator | Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care |
|
| Placebo | Placebo Comparator | Placebo drug plus standard care |
|
| Ivermectin (oral) alone | Active Comparator | Oral ivermectin 0.2mg/kg/day |
|
| Ivermectin (oral) with Zinc | Active Comparator | Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin Injectable Solution | Drug | Subcutaneous Ivermectin 200ug/kg body weight 48 hourly |
|
| Measure | Description | Time Frame |
|---|---|---|
| qRT-PCR | time needed to turn positive COVID-19 PCR to negative | 14 days |
| Time taken for alleviation of symptoms | time needed to turn off symptoms | upto 14 days |
| Severity of symptoms | time needed of symptom serverity | upto 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of symptoms | time needed to make patients clinically better | 14 days |
| Morality | death rate | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sohaib Ashraf, MBBS | Contact | +923334474523 | sohaib-ashraf@outlook.com | |
| Shoaib Ashraf, PhD | Contact | +16177949579 | sashraf@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Muhammad Ashraf, PhD | University of Veterinary & Animal Sciences, Lahore, Pakistan | Study Chair |
| Shoaib Ashraf, PhD | Harvard University Boston, USA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ali Clinic | Recruiting | Lahore | MA | 54600 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32293834 | Background | 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. | |
| 32283237 | Background | Patri A, Fabbrocini G. Hydroxychloroquine and ivermectin: A synergistic combination for COVID-19 chemoprophylaxis and treatment? J Am Acad Dermatol. 2020 Jun;82(6):e221. doi: 10.1016/j.jaad.2020.04.017. Epub 2020 Apr 10. No abstract available. |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D015032 | Zinc |
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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randomized, controlled, multi-armed, open-label, interventional study
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Empty capsule will sub-cutaneous injection of ivermectin will be used
| Zinc Alone | Active Comparator | 20mg Zinc Sulphate 8 hourly plus standard care |
|
| Injectable Placebo | Other | 0.9% normal saline |
|
|
| Zinc | Drug | Zinc Sulphate 20mg 3 times a day |
|
| Placebo empty capsule | Drug | Placebo empty capsule |
|
| Oral Ivermectin | Drug | 0.2mg/kg/day |
|
| Sohaib Ashraf, MBBS |
| Shaikh Zayed Medical Complex, Pakistan |
| Principal Investigator |
| Moneeb Ashraf, MBBS | Mayo Hospital, Pakistan | Principal Investigator |
| Shaikh Zayed Hospital | Recruiting | Lahore | Punjab Province | 54600 | Pakistan |
|
| 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. |
| 34488858 | Derived | Ashraf S, Ashraf S, Farooq I, Ashraf S, Ashraf M, Imran MA, Kalsoom L, Akmal R, Ghufran M, Rafique S, Akram MK, Habib Z, Siddiqui UN, Ahmad A, Arshad S, Virk MAR, Gul M, Awais AB, Hassan M, Sherazi SSH, Safdar Z, Munir I, Khalid H, Munir K, Majeed N, Alahmadi YM, Humayun A, Saboor QA, Ahmad A, Ashraf M, Izhar M; DOCTORS LOUNGE Consortium. Anti-COVID property of subcutaneous ivermectin in synergy with zinc among midlife moderately symptomatic patients: a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Sep 6;22(1):591. doi: 10.1186/s13063-021-05487-z. |
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D019216 |
| Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |