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Current Pharmacological Practices in Severe COVID-19

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ClinicalTrials.gov Identifier: NCT04691921
Recruitment Status : Completed
First Posted : December 31, 2020
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Prashant Nasa, NMC Specialty Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
COVID-19 Behavioral: Current clinical practices of participating physicians

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.

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Study Type : Observational
Actual Enrollment : 1055 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Nation-wide Cross-sectional Survey on Current Pharmacological Practices in Severe COVID-19
Actual Study Start Date : January 4, 2021
Actual Primary Completion Date : January 18, 2021
Actual Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Current clinical practices of participating physicians
    Current clinical practice of participating physicians on choice of pharmacological agents for clinical management of Severe COVID-19


Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Physicians involved in the clinical management of adult severe COVID-19 patients in India.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04691921


Locations
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India
Reliance Hospital
Mumbai, Mumbai, Mahrastra, India
Sponsors and Collaborators
NMC Specialty Hospital
Investigators
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Principal Investigator: Prashant Nasa, MD EDICM NMC Specialty Hospital
Additional Information:
Publications of Results:
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Responsible Party: Prashant Nasa, Specialist Critical Care Medicine, NMC Specialty Hospital
ClinicalTrials.gov Identifier: NCT04691921    
Other Study ID Numbers: NMCSH
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No