Proof of Concept Study of Ketoji (Liquid) for its Effectiveness in Treatment and Management of COVID-19 Patients

Not Applicable

Completed

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

• Registration Number: CTRI/2020/10/028231
• Lead Sponsor: Dr Kapil G Zirpe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-12-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

a. Patients of either sex, 18 to 75 years of age (both inclusive).

b. Patients with diagnosis of coronavirus (SARS-CoV-2) infection conformed by polymerase chain reaction (PCR) test and sign of mild acute respiratory infection or with respiratory stress.

c. Patients with body muscle pain/fatigue.

d. Able to abide the dietary regime mentioned by the investigator.

e. Willing to come for regular follow â??up visits.

f. Able to give written informed consent.

Exclusion Criteria

a. Known history of hypersensitivity to dietary supplements.

b. Volunteers receiving any COVID-19 specific antiviral treatment.

c. Concurrent respiratory diseases such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days) prior to COVID-19 diagnosis.

d. Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I.

e. Volunteers having systemic diseases like diabetes mellitus (Type I or Type II) and other debilitating metabolic diseases.

f. Pregnant or lactating women

g. Female subjects of childbearing potential not willing to use contraceptive methods

h. Male subjects not willing to use contraceptive methods

i. On-going treatment with herbals or any other immune boosting dietary supplements.

j. History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing.

k. Patients with ARDS of Cardiac origin

l. Any condition that in the opinion of the investigator does not justify the patientâ??s inclusion for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from the baseline in <br/ ><br>1 Body Temperature and Pulmonary Function Tests (FVC, FEV1) by Spirometer. <br/ ><br>2 pO2, pCO2 (blood gas analysis) showing improvement P/ F ratio as 300 <br/ ><br>3 Subjectâ??s feedback on muscle fatigue and overall well-being, atleast 5 days from last visit (post COVID-19). <br/ ><br>4 Chest X Ray or CT shows improved pulmonary edema or bilateral, patchy alveolar opacities/ consolidations â??â??white lungâ??â?? appearance.Timepoint: From Baseline Day 0 to Day 5

Secondary Outcome Measures

Name	Time	Method
1) Immune marker (IL-1β, IL-6, IL-10, IL-18, TNF- α) levels on Day 5. <br/ ><br>2 Reduction in muscle fatigue by Serum Creatine Kinase, Lactate (biomarkers) on Day 5. <br/ ><br>3 Number of subjects not in need of oxygen supply <br/ ><br>4 Number of subjects not in need of mechanical invasive or non-invasive ventilation <br/ ><br>5 If ventilation is required, then time to wean off mechanical invasive or non-invasive ventilation <br/ ><br>6 Change in basic haematology and serum biochemistry (LFT, RFT) panel values. <br/ ><br>7 Adverse eventsTimepoint: From Baseline Day 0 to Day 5