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The objective of this study is to measure the effect of Iodine complex 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.
The proposed study is a placebo-controlled, add-on, randomized trial using parallel group designs. This is a close-label and adaptive, multi-centered design with 1:1:1:1 allocation ratio and superiority framework.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iodine Complex (Capsule form) | Experimental | Iodine Complex) capsule (200mg) will be given three times a day |
|
| Iodine Complex (Syrup form) | Experimental | Iodine Complex syrup form (40ml) will be given three times a day |
|
| Standard Care Alone | Placebo Comparator | Placebo as empty capsule. Treatment will be given for all 4 arms will be receiving standard care as per version 3.0 of clinical management guidelines for COVID-19 established by the Ministry of National Health Services of Pakistan COVID-19 guidelines of the study setting. |
|
| Iodine Complex (Nasal Spray) | Experimental | Iodine complex throat spray of 2 puffs three times a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodine Complex | Drug | Iodine Complex capsule (200mg) will be given three times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| qRT-PCR | Time taken for viral load clearance | 14 days |
| HRCT chest | Time taken for radiological improvement | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Symptoms | Time taken for symptomatic response in patients | 14 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, Pakistan | Study Chair |
| Shoaib Ashraf, PhD | Harvard University, Massachusetts General Hospital, Boston, USA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaikh Zayed Hospital | Recruiting | Lahore | 54600 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35045888 | Derived | Ashraf S, Ashraf S, Ashraf M, Farooq I, Akmal R, Imran MA, Kalsoom L, Ashraf S, Rafique S, Ghufran M, Akram MK, Sohaib-Ur-Rehman, Nadeem MF, Matti N, Siddiqui UN, Humayun A, Saboor QA, Ahmad A, Ashraf M, Izhar M; DOCTORS LOUNGE consortium. Clinical efficacy of iodine complex in SARS-CoV-2-infected patients with mild to moderate symptoms: study protocol for a randomized controlled trial. Trials. 2022 Jan 19;23(1):58. doi: 10.1186/s13063-021-05848-8. | |
| 33568226 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002214 | Capsules |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Randomized, controlled, multi-armed, close-label, interventional study designed
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empty capsule will be given as a placebo
| Iodine Complex | Drug | Iodine Complex syrup form (40ml) will be given three times a day |
|
| Placebo | Drug | Empty capsule will be given as placebo |
|
|
| Idoine Complex | Drug | Iodine Complex spray form 2 puffs will be given three times a day |
|
| Moneeb Ashraf, MBBS | Mayo Hospital, Pakistan | Principal Investigator |
| Sohaib Ashraf, MBBS | Shaikh Zayed Medical Complex, Pakistan | Principal Investigator |
| Derived |
| Ashraf S, Ashraf S, Ashraf M, Imran MA, Kalsoom L, Siddiqui UN, Farooq I, Ghufran M, Khokhar RA, Akram MK, Shahid I, Sohaib Ur Rehman M, Akmal R, Tahir A, Zahid A, Ashraf S, Rafique S, Matti N, Nadeem MF, Humayun A, Malik A, Saboor QA, Ahmad A, Ashraf M, Izhar M. A quadruple blinded placebo controlled randomised trial to evaluate the effectiveness of an Iodine complex for patients with mild to moderate COVID-19 in Pakistan (I-COVID-PK): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Feb 10;22(1):127. doi: 10.1186/s13063-021-05081-3. |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |