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Community-based Post-exposure Prophylaxis for COVID-19

Primary Purpose

Covid19

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Guduchi Ghanvati

Standard guidelines

About this trial

This is an interventional prevention trial for Covid19 focused on measuring Post Exposure Prophylaxis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Men or women 18 to 60 years of age
Household contact residing with the index case in the 14 days prior to index diagnosis within a residence without maintaining social distance
Access to device and internet for telephonic appointments and follow up

Exclusion Criteria:

Currently hospitalised
Symptomatic with fever, cough, or shortness of breath
Use of anti-malarial treatment or chemoprophylaxis
Moderately or Severely ill for any co-morbid condition requiring medical assistance.
Cognitive impairment

Sites / Locations

NMP Medical Research Institute
Padmnabham Ayurveda Hospital & Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ayurveda Care Group

Usual Care Group

Arm Description

Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask Samshamani vati or Giloy Ghanavati

Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask

Outcomes

Primary Outcome Measures

Number of participants with active COVID-19

PCR- proven COVID-19

Secondary Outcome Measures

Time to symptoms onset

Days until start of symptoms of COVID-19

Disease Severity

Visual Analog Scale of rating overall symptom severity (0 = no symptoms; 10 = most severe)

Full Information

NCT ID

NCT04920773

First Posted

June 6, 2021

Last Updated

June 9, 2021

Sponsor

NMP Medical Research Institute

Collaborators

Aarogyam UK, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Samta Ayurveda Prakoshtha, India, Padmanabhama Ayurveda Hospital and Research Centre

1. Study Identification

Unique Protocol Identification Number

NCT04920773

Brief Title

Community-based Post-exposure Prophylaxis for COVID-19

Official Title

Community-based Post-exposure Prophylaxis for COVID-19: Results and Implications of Ayurveda Practice Guidelines

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

May 3, 2021 (Actual)

Primary Completion Date

May 21, 2021 (Actual)

Study Completion Date

June 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NMP Medical Research Institute

Collaborators

Aarogyam UK, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Samta Ayurveda Prakoshtha, India, Padmanabhama Ayurveda Hospital and Research Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Specifically identified Ayurvedic preparations is recommended by ministry of AYUSH as post-exposure prophylaxis to efficaciously prevent a negative person who has come into contact with COVID-19-positive. Traditionally, recommended Ayurvedic preparations have been used as antioxidants, antimicrobial and anti-inflammatory properties. Particularly, Guduchi Ghanvati has been recognised with its ability to control viral attachment, viral replication and induce immune response in pre clinical settings, and found to be one among the most important drugs in Ayurveda to fight against COVID-19. However, known gap in guideline implementation and its impact on preventing active infection in exposed cases is unclear. Study aimed to increase the use of recommended AYUSH guidelines by having registered AYUSH physicians provide these medications, when indicated, in community based participants after known exposure to the SARS-CoV-2 coronavirus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

Post Exposure Prophylaxis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

216 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ayurveda Care Group

Arm Type

Experimental

Arm Description

Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask Samshamani vati or Giloy Ghanavati

Arm Title

Usual Care Group

Arm Type

Active Comparator

Arm Description

Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask

Intervention Type

Other

Intervention Name(s)

Guduchi Ghanvati

Intervention Description

500 mg of Samshamani vati or Giloy Ghanavati (Aqueous extract of Tinospora cordifolia) twice daily

Intervention Type

Other

Intervention Name(s)

Standard guidelines

Intervention Description

Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask

Primary Outcome Measure Information:

Title

Number of participants with active COVID-19

Description

PCR- proven COVID-19

Time Frame

14-days following exposure

Secondary Outcome Measure Information:

Title

Time to symptoms onset

Description

Days until start of symptoms of COVID-19

Time Frame

14-days

Title

Disease Severity

Description

Visual Analog Scale of rating overall symptom severity (0 = no symptoms; 10 = most severe)

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men or women 18 to 60 years of age Household contact residing with the index case in the 14 days prior to index diagnosis within a residence without maintaining social distance Access to device and internet for telephonic appointments and follow up Exclusion Criteria: Currently hospitalised Symptomatic with fever, cough, or shortness of breath Use of anti-malarial treatment or chemoprophylaxis Moderately or Severely ill for any co-morbid condition requiring medical assistance. Cognitive impairment

Overall Study Officials: