A clinical trial to know the effect of Virulina® along with standard treatment in covid 19 positive patients.

Not Applicable

Completed

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

• Registration Number: CTRI/2020/06/025556
• Lead Sponsor: atural Solutions

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-08-21
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. Either male or female of age range 18-70 years.

2. Recent history of contact with Covid-19 positive people and are advised to be quarantined or has symptoms which include cough, fever with or without chills and difficulty in breathing (Time interval between symptoms onset and randomization to be not more than 7 days)

3. Patients with laboratory confirmation of infection with SAARS-CoV-2 by positive RT-PCR (within 48 hrs prior to randomization)

Subjects willing to give written informed consent and come for a regular follow up

4. Subjects willing to abide by and comply with the study protocol

Exclusion Criteria

1. Patients presenting severe multisystemic symptoms compatible with advanced Covid-19 and intercurrent acute or severe chronic diseases (i.e. active cancer).

2. Presence of acute hypoxic respiratory failure

3. Requires Intensive care unit (ICU) care for management of ongoing clinical status

4. Severe infection, defined as need for invasive or non- invasive ventilator support

5. Inability to intake or tolerate oral medication

6. Category 6 or 5 based on modified 7-category ordinal

scale of clinical status

7. Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission

8. Pregnant subjects

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time until cessation of oral shedding of SAARS-CoV- 2 virus (Time in days from randomization to a negative SAARS-Cov-2 RT-PCR result of both oropharyngeal swab and nasopharyngeal swab). <br/ ><br>Time point-Up to 14 days <br/ ><br>- Clinical cure based on Clinicianâ??s assessment of symptoms which include cough relief, recovery from fever and difficulty in breathing for the period they are in quarantine. (For those patients who presented with clinical signs and symptoms at baseline).Timepoint: Day 1, Day 7 and Day 14

Secondary Outcome Measures

Name	Time	Method
Improvement in the clinical lab variables <br/ ><br>Subject global assessment of symptoms <br/ ><br>Composite of cumulative death (i.e. mortality) for all causes and for specific causes. <br/ ><br>Necessity of invasive assisted ventilation <br/ ><br>Necessity of non-invasive assisted ventilation <br/ ><br>Intensive care unit admission <br/ ><br>Post-anesthesia care unit admission <br/ ><br>Hospital admission <br/ ><br>Medical consultation <br/ ><br>Home care and isolation time <br/ ><br>Bed rest time <br/ ><br>symptoms durationTimepoint: Day 1, Day 7 and Day 14.