Community-based Post-exposure Prophylaxis for COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2021-06-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ayurveda Care Group

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

Group Type EXPERIMENTAL

Guduchi Ghanvati

Intervention Type OTHER

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

Standard guidelines

Intervention Type OTHER

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

Usual Care Group

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

Group Type ACTIVE_COMPARATOR

Standard guidelines

Intervention Type OTHER

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

Interventions

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Guduchi Ghanvati

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

Intervention Type OTHER

Standard guidelines

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes