Community-based Post-exposure Prophylaxis for COVID-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04920773
• Other study ID #: NMP/CARE/01
• Status: Completed
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: June 6, 2021

Study information

• Verified date: June 2021
• Source: NMP Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: June 6, 2021
• Est. primary completion date: May 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• Guduchi Ghanvati
500 mg of Samshamani vati or Giloy Ghanavati (Aqueous extract of Tinospora cordifolia) twice daily
• Standard guidelines
Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask

Locations

Country	Name	City	State
India	NMP Medical Research Institute	Jaipur	Rajasthan
India	Padmnabham Ayurveda Hospital & Research Center	Jaipur	Rajasthan

Sponsors (5)

Lead Sponsor	Collaborator
NMP Medical Research Institute	Aarogyam UK, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Padmanabhama Ayurveda Hospital and Research Centre, Samta Ayurveda Prakoshtha, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with active COVID-19	PCR- proven COVID-19	14-days following exposure
Secondary	Time to symptoms onset	Days until start of symptoms of COVID-19	14-days
Secondary	Disease Severity	Visual Analog Scale of rating overall symptom severity (0 = no symptoms; 10 = most severe)	14 days