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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04473261
Other study ID # SZMC/IRB/Internal/216/2020
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 14, 2020
Est. completion date October 15, 2021

Study information

Verified date July 2021
Source Sheikh Zayed Federal Postgraduate Medical Institute
Contact Sohaib Ashraf, MBBS
Phone +923334474523
Email sohaib-ashraf@outlook.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 15, 2021
Est. primary completion date August 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Positive PCR with mild to moderate disease Exclusion Criteria: - Allergic to iodine - Any co-morbidity other than hypertension and dietetics

Study Design


Intervention

Drug:
Iodine Complex
Iodine Complex capsule (200mg) will be given three times a day
Iodine Complex
Iodine Complex syrup form (40ml) will be given three times a day
Placebo
Empty capsule will be given as placebo
Idoine Complex
Iodine Complex spray form 2 puffs will be given three times a day

Locations

Country Name City State
Pakistan Shaikh Zayed Hospital Lahore

Sponsors (1)

Lead Sponsor Collaborator
Sohaib Ashraf

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary qRT-PCR Time taken for viral load clearance 14 days
Primary HRCT chest Time taken for radiological improvement 14 days
Secondary Severity of Symptoms Time taken for symptomatic response in patients 14 days
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