Can ProGenX resolve Post-COVID Fatigue and improve Immune Status?

Phase 3

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

• Registration Number: CTRI/2022/04/041704
• Lead Sponsor: ihar Ranjan Pradhan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Males or non-pregnant, non-lactating females aged - 18 to 75 years (both inclusive);

RT-PCR confirmed diagnosis of COVID-19 at any time followed by an RT-PCR negative test;

Patients experiencing fatigue and muscle weakness;

Able to take the drug orally and comply with study procedures;

Women of childbearing potential with a negative urine pregnancy test.

Exclusion Criteria

Prior known respiratory distress (RR-30 times/min);

Finger oxygen saturation < 90% in a resting state,

Arterial partial pressure of oxygen(pao2)/concentration of oxygen inhalation (Fio2) <300 mmHg;

Respiratory failure or on mechanical ventilation,

In shock;

ICU needed for other organ failure;

Patients with other viral pneumonia;

Patients unable to take food or drugs due to coma or intestinal obstruction;

Consumption of other oral probiotic supplements during the trial;

Patients with severe underlying diseases that affects survival, including uncontrolled malignant tumor with multiple metastases that cannot be resected;

Blood diseases

Dyscrasia;

Active bleeding

Severe malnutrition

Women who are pregnant or lactating

Subjects (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation) during the study period;

Patients allergic to systemic enzyme supplements;

Patients facing imminent death in the opinion of the clinical team;

Patients with Hb less than 10 g/dl;

Patients who have participated in any other clinical study within 2 weeks prior to randomization

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of patients showing improvement in physical fatigue on CFQ-11 and the proportion of patients showing improvement in mental fatigue on CFQ-11.Timepoint: Day 30

Secondary Outcome Measures

Name	Time	Method
Change in the following parameters <br/ ><br>CRP <br/ ><br>Imunoglobulins ââ?¬â?? IgA, IgM and IgG <br/ ><br>Antinuclear antibody <br/ ><br>Total Protein <br/ ><br>Complete Blood Count with a five-part differential to determine total white cells, total lymphocytes and total eosinophilTimepoint: Day 30