Efficacy of Iodine Complex Against COVID-19 Patients (I-COVID-PK)

Sohaib Ashraf

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Corona Virus Infection; Covid19; SARS-CoV-2

Treatments: Drug: Iodine Complex; Drug: Idoine Complex; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04473261

SZMC/IRB/Internal/216/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive PCR with mild to moderate disease

Exclusion criteria

• Allergic to iodine
• Any co-morbidity other than hypertension and dietetics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

Iodine Complex (Capsule form)

Experimental group

Description:

Iodine Complex) capsule (200mg) will be given three times a day

Treatment:

Drug: Iodine Complex

Drug: Iodine Complex

Iodine Complex (Syrup form)

Experimental group

Description:

Iodine Complex syrup form (40ml) will be given three times a day

Treatment:

Drug: Iodine Complex

Drug: Iodine Complex

Standard Care Alone

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Iodine Complex (Nasal Spray)

Experimental group

Description:

Iodine complex throat spray of 2 puffs three times a day.

Treatment:

Drug: Idoine Complex