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Current Pharmacological Practices in Severe COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date December 30, 2020
First Posted Date December 31, 2020
Last Update Posted Date February 16, 2021
Actual Study Start Date January 4, 2021
Actual Primary Completion Date January 18, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 30, 2020)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Current Pharmacological Practices in Severe COVID-19
Official Title Nation-wide Cross-sectional Survey on Current Pharmacological Practices in Severe COVID-19
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.

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
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Physicians involved in the clinical management of adult severe COVID-19 patients in India.
Condition COVID-19
Intervention 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
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 13, 2021)
1055
Original Estimated Enrollment
 (submitted: December 30, 2020)
1000
Actual Study Completion Date January 31, 2021
Actual Primary Completion Date January 18, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries United Arab Emirates
 
Administrative Information
NCT Number NCT04691921
Other Study ID Numbers NMCSH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Prashant Nasa, NMC Specialty Hospital
Study Sponsor NMC Specialty Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Prashant Nasa, MD EDICM NMC Specialty Hospital
PRS Account NMC Specialty Hospital
Verification Date February 2021