Current Pharmacological Practices in Severe COVID-19

February 13, 2021 updated by: Prashant Nasa, NMC Specialty Hospital

Nation-wide Cross-sectional Survey on Current Pharmacological Practices in Severe COVID-19

The investigators aim to understand the variation in pharmacological therapies for the management of severe coronavirus disease 2019 (COVID-19) in India and compare it to the recent available evidence.

The ongoing pandemic of COVID-19 has proven to be the greatest medical emergency of recent times. The evidence on the therapeutics has evolved significantly in last few months after initial use of re-purposed drugs.

The objective of this study is to understand the current practices in the management of adults severe COVID-19 in India.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The ongoing pandemic of COVID-19 has proven to be the greatest medical emergency of recent times. The response of the medical world to this crisis has been unprecedented. The healthcare workers are caring for patients at the frontline while, scientists and researchers are discovering vaccines or effective treatment in shortest possible duration. The scale and effect of pandemic in India, being second most populous country of the world is enormous. As of December 30, 2020, India has crossed 10 million cases and 148,000 deaths from COVID-19. India has second most number of cases only after United States of America (USA) and with third largest number of deaths. The Ministry of Health and family Welfare (Under Government of India) has given periodical clinical management guidelines, with last updated on July 5, 2020 (version 5).

In adults, severe COVID-19 is defined as presence of any of the following dyspnea, a respiratory rate of 30 or more breaths per minute, a blood oxygen saturation (SpO2) of 93% or less, a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (Pao2:Fio2) of less than 300 mm Hg, or infiltrates in more than 50% of the lung field while Critical COVID-19 is defined as presence of acute respiratory distress syndrome (ARDS), sepsis or septic shock. The mortality in critical COVID-19 is reported to be 25-49% in different studies. The evidence on the therapeutics for COVID-19 has evolved significantly in last few months after initial use of re-purposed drugs. There are no recent guidelines available based on the current evidence for clinical management of COVID-19.

The investigators are planning for nation-wide multicentre cross-sectional survey on understanding participating physicians practices on choice of different pharmacotherapeutic agents available in India as of January 2021.

The objective of this study is to understand the current practices of participating physicians in the management of adult patients with severe COVID-19 in India and to determine future priorities.

Study Type

Observational

Enrollment (Actual)

1055

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Mumbai, Mahrastra
      • Mumbai, Mumbai, Mahrastra, India
        • Reliance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Physicians involved in the clinical management of adult severe COVID-19 patients in India.

Description

Inclusion Criteria:

Physicians who are involved in management of adult patients with severe COVID-19 in India

Exclusion Criteria:

Pediatrician Physicians who are not managing severe COVID-19 patients or refused to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Choice and indication of pharmacological agents for management of Severe COVID-19
Time Frame: two weeks
Cross-sectional survey will capture the current choice and indication of different pharmacological agents for management of Severe COVID-19 among participating physicians in India
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NMC Specialty Hospital

Investigators

  • Principal Investigator: Prashant Nasa, MD EDICM, NMC Specialty Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2021

Primary Completion (Actual)

January 18, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

December 30, 2020

First Submitted That Met QC Criteria

December 30, 2020

First Posted (Actual)

December 31, 2020

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 13, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMCSH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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