Safety and efficacy of citrobioShield product in improving immunity in COVID 19 patients via inhalation.

Not Applicable

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/08/027085
• Lead Sponsor: GERMKILL INDIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-09-10
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1.Male or non-pregnant female between 18 to 65 years of age at the time of enrolment.

2.Subject or LAR providing written informed consent and agrees to follow study procedure.

3.Woman with child bearing potential confirming use of primary contraception

4.Mild to moderate freshly confirmed COVID 19 positive subjects in less than 24 hours not requiring emergency or ICU care at the time of enrolment

Exclusion Criteria

1.Severe COVID 19 patients requiring ventilation or oxygen support when diagnosed.

2.Females who are planning to conceive during the study duration or are pregnant already or are breastfeeding.

3.Subjects having serious or unstable respiratory disorders (self-reported)

4.Subject already on immune therapy (self-reported)

5.Immunodeficiency or organ transplant (self-reported)

6.Autoimmune disease (self-reported)

7.Current acute infection or exacerbation of a chronic illness (self-reported)

8.Cancer within last 5 years (self-reported)

9.Known infection with HIV, Hepatitis B & Hepatitis C (self-reported)

10.Drug abuse/alcohol abuse (self-reported)

11.Plasma donation within last 4 months (self-reported)

12.Receiving blood or immunoglobulins within 3 months (self-reported)

13.SGOT/SGPT greater than 5 times normal value (self-reported)

Study & Design

• Study Type: Interventional
• Study Design: Not specified