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Baricitinib in Hospitalized Covid-19 Patients With Diabetes Mellitus

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04970719
Recruitment Status : Recruiting
First Posted : July 21, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Wasim Md Mohosin Ul Haque, Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders

Brief Summary:
To date, some of the most promising drugs used in the treatment of COVID pneumonia are systemic corticosteroids, remdesivir and baricitinib. Dexamethasone has been found efficacious in reducing mortality in patients requiring supplemental oxygen and mechanical ventilation. There is a trend towards reduced mortality in patients who receive remdesivir and dexamethasone combination, supporting the hypothesis that an antiviral drug combined with an anti-inflammatory agent improve outcomes in COVID-19. Baricitinib plus remdesivir is superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with COVID-19, notably among those receiving high-flow oxygen non-invasive ventilation. Diabetes mellitus increases the risk for COVID-19 morbidity and mortality. Patients with diabetes have coexisting morbidities and already immune-compromised. Steroids cause further immunosuppression and may contribute to uncontrolled blood glucose in this group of patients, resulting in worse outcomes. Baricitinib can be an alternative to corticosteroids in diabetic patients. This open-label multi-centre non-inferiority randomized controlled trial will be conducted in seven hospitals in Bangladesh. The primary objective is to evaluate the clinical efficacy of baricitinib plus remdesivir compared to dexamethasone plus remdesivir in hospitalized COVID-19 patients with diabetes mellitus, as assessed by the proportion of patients, need "rescue treatment" between two groups by day 29. Hospitalized adult (≥18 years) diabetic patients with confirmed SARS-CoV-2 infection have ordinal scale category 5 will be included in the study. Subjects will be randomized in a 1:1 (by tossing a coin) ratio in two groups. The total sample size is 362. Group 1 subjects will receive 200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily dose of remdesivir while hospitalized for up to 5 days and 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to 14 days. Group 2 will receive the same dose of remdesivir plus 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to 10 days. Subjects will be assessed daily while hospitalized. Discharged subjects will be evaluated on days 15, 22 and 29 (in person; if not possible, over the telephone). Assessment will be done clinically using an 8-point Ordinal Scale and National Early Warning Score.

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Drug: Baricitinib Drug: Dexamethasone Drug: Remdesivir Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Baricitinib Plus Remdesivir Compared to Dexamethasone Plus Remdesivir in Hospitalised COVID-19 Patients With Diabetes Mellitus
Actual Study Start Date : July 10, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Remdesivir plus Baricitinib
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 5-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course
Drug: Baricitinib
4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course
Other Name: Janus kinase inhibitors

Drug: Remdesivir
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 5-day total course
Other Name: Anti-viral

Active Comparator: Remdesivir plus Dexamethasone
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 5 -day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
Drug: Dexamethasone
and 6 mg* of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course
Other Name: Steroids

Drug: Remdesivir
200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 5-day total course
Other Name: Anti-viral




Primary Outcome Measures :
  1. Rescue treatment [ Time Frame: Day 2 through Day 29 ]

    The proportion of subjects not requiring "rescue treatment".

    Rescue treatment will be given if there is a deterioration of the ordinal scale beyond category 5 (unable to maintain SpO2 ≥ 92% with 10 L/ min O2) at any time 24 hours after enrollment.

    10 mg of dexamethasone will be administered on top of existing treatment in group 1 and escalate to in group 2 as an intravenous injection, 2 to 4 times daily for 3 to 5 days based on the patient's condition, then tapered.

    Patients who deteriorate beyond the ordinal scale category 5 within 24 hours of enrollment will be excluded from the study.



Secondary Outcome Measures :
  1. Death or invasive mechanical ventilation [ Time Frame: Day 2 through Day 29 ]
    The proportion of subjects not meeting criteria for one of the following two ordinal scale categories at any time: 8) Death; 7) Hospitalized, on invasive mechanical ventilation

  2. C-reactive protein (CRP) [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in C-reactive protein (CRP)

  3. lactate dehydrogenase (LDH) [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in lactate dehydrogenase (LDH)

  4. Ferritin [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in Ferritin

  5. Creatinine [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in creatinine

  6. alanine aminotransferase (ALT) [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in alanine aminotransferase (ALT)

  7. d-dimer concentration [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in d-dimer concentration

  8. fasting blood glucose (FBS) [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in fasting blood glucose (FBS)

  9. hemoglobin [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in hemoglobin

  10. platelets [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in platelets

  11. white blood cell count (WBC) [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in white blood cell count (WBC)

  12. total lymphocyte count [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in total lymphocyte count

  13. adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]
    Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs)

  14. serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]
    Cumulative incidence of serious adverse events (SAEs) An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.

  15. invasive mechanical ventilation [ Time Frame: Day 2 through Day 29 ]
    Days of invasive mechanical ventilation (if applicable)

  16. non-invasive ventilation/high flow oxygen [ Time Frame: Day 2 through Day 29 ]
    Days of non-invasive ventilation/high flow oxygen (if applicable)

  17. supplemental oxygen [ Time Frame: Day 1 through Day 29 ]
    Days of supplemental oxygen

  18. Desirability of Outcome Ranking (DOOR) [ Time Frame: Day 15 through Day 29 ]
    Desirability of Outcome Ranking (DOOR) based on ordinal scale: 1) Recovered (category 1, 2 or 3 on ordinal scale); 2) Improved (> / = 1 category improvement of ordinal scale compared with baseline) & no serious adverse event (SAE); 3) Improved (> / = 1 category improvement of the ordinal scale compared with baseline) & SAE (related or unrelated); 4) No change in ordinal scale from baseline & no SAE; 5) No change in ordinal scale from baseline & SAE (related or unrelated); 6) Worsening (> / = 1 category worse in ordinal scale from baseline); 7) Death.

  19. Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]
    Measured in days

  20. Incidence of discontinuation or temporary suspension of study product administration [ Time Frame: Day 1 through Day 10 ]
    For any reason

  21. Subject 14-day mortality [ Time Frame: Day 2 through Day 15 ]
    Date of death (if applicable).

  22. Subject 28-day mortality [ Time Frame: Day 2 through Day 29 ]
    Date of death (if applicable).

  23. Subject clinical status [ Time Frame: Days 3, 5, 8, 11, 15, 22, and 29 ]
    The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use

  24. The proportion of subjects meeting criteria for each of the 8 ordinal scale categories [ Time Frame: Day 15 ]
    The ordinal scale categories are defined as: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use

  25. The proportion of subjects not meeting criteria for one of the three most severe ordinal scale categories at any time [ Time Frame: Day 2 through Day 29 ]
    The ordinal scale categories: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices.

  26. Time to an improvement of one category from baseline using an ordinal scale [ Time Frame: Day 1 through Day 29 ]
    The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has a new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, the patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.

  27. Time to recovery [ Time Frame: Day 1 through Day 29 ]
    Day of recovery is defined as the first day on which the subject satisfies one of the following three ordinal scale categories: 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized diabetic adults with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) in any respiratory specimen within 10 days prior to randomization or *Hospitalized diabetic adults with typical features of COVID-19 for 10 days prior to randomization, not yet tested for SARS-CoV-2 infection by PCR in any respiratory specimen.

    • RT-PCR for SARS-CoV-2 will be performed within 48 hours of enrollment and excluded from the study if found to be negative.
  • 8-point ordinal scale "category 5" patients, but O2 requirement not more than 10L / min.
  • The subject provides informed consent before initiating any study procedures and understands and agrees to comply with planned study procedures

Exclusion Criteria:

  • Patients with evidence (clinical, hematological, microbiological or imaging ) of sepsis or any acute/subacute coinfection at the time of enrollment.
  • Patients who have already received any of the study drugs prior to randomization.
  • Patients with severe renal and/or hepatic impairment (eGFR <30 mL/min [EPI-CKD formula] or serum ALT more than 5 times normal upper limit, serum bilirubin > 2 mg/dl).
  • Patients with known COPD.
  • Patients with absolute neutrophil count <700 cells/microliter, 0.7 x 103/microliter.
  • Patients with absolute lymphocyte count <200 cells/microliter, 0.20 x 103/microliter.
  • Patients who are allergic to any of the study drugs.
  • Patients with chronic infections, such as tuberculosis (TB), HIV infection etc.
  • Immunosuppressed patients, such as taking cytotoxic/immunomodulating drugs or systemic steroid.

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): NCT04970719


Contacts
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Contact: Wasim MM Haque, FCPS +8801915472750 wmmhaque@live.com
Contact: Md D Hossain, MD +8801819218238 delwarhschest64@gmail.com

Locations
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Bangladesh
Bangabandhu Sheikh Mujib Medical University Not yet recruiting
Dhaka, Bangladesh, 1000
Contact: Shohael M Arafat, FCPS    +8801732330313    arafat2001@gmail.com   
Principal Investigator: Shohael M Arafat, FCPS         
Sub-Investigator: Abul K Azad, FCPS         
Sub-Investigator: MOHAMMAD T ISLAM, FCPS         
Sub-Investigator: MOHAMMAD F RAHAMAN, FCPS         
Sub-Investigator: Abed H Khan, FCPS         
Sub-Investigator: MD N HASAN, FCPS         
BIRDEM General Hospital Recruiting
Dhaka, Bangladesh, 1000
Contact: Wasim MM Haque, FCPS    +8801915472750    wmmhaque@live.com   
Contact: Md D Hossain, MD    +8801819218238    delwarhschest64@gmail.com   
Principal Investigator: Wasim MM Haque, FCPS         
Sub-Investigator: Md D Hossain, MD         
Sub-Investigator: Md R Rahman, MD         
Sub-Investigator: A.K.M. S Ahmed, FCPS         
Sub-Investigator: Jamal U Ahmed, FCPS         
Sub-Investigator: ASM A Ahsan, FCPS         
Sub-Investigator: Md R Islam, FCPS         
Sub-Investigator: Hasna F Haque, FCPS         
Sub-Investigator: Farhana Afroz, FCPS         
Sub-Investigator: Samira R Afroze, FCPS         
Sub-Investigator: Md J Islam, FCPS         
Sub-Investigator: Rene Suzan C Sarker, FCPS         
Sub-Investigator: Azimunnessa, FCPS         
Sub-Investigator: Md Z Alam, FCPS         
Sub-Investigator: Muhammad A Rahim, FCPS         
Sub-Investigator: Mehruba Alam, FCPS         
Sub-Investigator: Rumana Habib, FCPS         
Sub-Investigator: Rezaul Irfan, FCPS         
Sub-Investigator: Ashraf U Ahmed, FCPS         
Sub-Investigator: Shudhanshu K Saha, FCPS         
Sub-Investigator: Dilruba Alam, FCPS         
Sub-Investigator: Mohammad SH Khan, FCPS         
Sub-Investigator: Sharker MD Sazzad, MRCP         
Mugda Medical College and Hospital Recruiting
Dhaka, Bangladesh, 2015
Contact: RUBINA YASMIN, FCPS    +8801712009387    drrubina_yasmin@yahoo.com   
Principal Investigator: RUBINA YASMIN, FCPS         
Sub-Investigator: Md M Haque, FCPS         
Sub-Investigator: Ahsanul Hoque, FCPS         
Sub-Investigator: Nandita Paul, FCPS         
Sub-Investigator: Nazim Al Azad, FCPS         
Sub-Investigator: Rahnuma Parveen, FCPS         
Bangladesh Specialized Hospital Recruiting
Dhaka, Bangladesh
Contact: Mohiuddin Ahmed, FCPS    +8801714046154    m77ahmed@gmail.com   
Principal Investigator: Mohiuddin Ahmed, FCPS         
Central Police Hospital Recruiting
Dhaka, Bangladesh
Contact: Zahid Amin, FCPS    +8801818778671    dr.zahidamin@gmail.com   
Principal Investigator: Zahid Amin, FCPS         
SQUARE Hospitals Limited Not yet recruiting
Dhaka, Bangladesh
Contact: Raihan Rabbani, FCPS    +880 1754544689    raihanrabbani@yahoo.com   
Principal Investigator: Raihan Rabbani, FCPS         
Khulna Medical College Hospital Not yet recruiting
Khulna, Bangladesh
Contact: Khosrul A Mollick, MD    +8801838458953    khosrul4@gmail.com   
Principal Investigator: Khosrul A Mollick, MD         
Rajshahi Medical College & Hospital Recruiting
Rajshahi, Bangladesh
Contact: MD K RAHMAN, FCPS    +8801711-302261    drkhalil64@yahoo.com   
Principal Investigator: MD K RAHMAN, FCPS         
Sub-Investigator: Md A Haque, FCPS         
Sponsors and Collaborators
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
Investigators
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Principal Investigator: Wasim MM Haque, FCPS BIRDEM General Hospital
Publications of Results:
Kalil AC, Patterson TF, Mehta AK, Tomashek KM, Wolfe CR, Ghazaryan V, Marconi VC, Ruiz-Palacios GM, Hsieh L, Kline S, Tapson V, Iovine NM, Jain MK, Sweeney DA, El Sahly HM, Branche AR, Regalado Pineda J, Lye DC, Sandkovsky U, Luetkemeyer AF, Cohen SH, Finberg RW, Jackson PEH, Taiwo B, Paules CI, Arguinchona H, Erdmann N, Ahuja N, Frank M, Oh MD, Kim ES, Tan SY, Mularski RA, Nielsen H, Ponce PO, Taylor BS, Larson L, Rouphael NG, Saklawi Y, Cantos VD, Ko ER, Engemann JJ, Amin AN, Watanabe M, Billings J, Elie MC, Davey RT, Burgess TH, Ferreira J, Green M, Makowski M, Cardoso A, de Bono S, Bonnett T, Proschan M, Deye GA, Dempsey W, Nayak SU, Dodd LE, Beigel JH; ACTT-2 Study Group Members. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. N Engl J Med. 2021 Mar 4;384(9):795-807. doi: 10.1056/NEJMoa2031994. Epub 2020 Dec 11.
WHO Solidarity Trial Consortium, Pan H, Peto R, Henao-Restrepo AM, Preziosi MP, Sathiyamoorthy V, Abdool Karim Q, Alejandria MM, Hernández García C, Kieny MP, Malekzadeh R, Murthy S, Reddy KS, Roses Periago M, Abi Hanna P, Ader F, Al-Bader AM, Alhasawi A, Allum E, Alotaibi A, Alvarez-Moreno CA, Appadoo S, Asiri A, Aukrust P, Barratt-Due A, Bellani S, Branca M, Cappel-Porter HBC, Cerrato N, Chow TS, Como N, Eustace J, García PJ, Godbole S, Gotuzzo E, Griskevicius L, Hamra R, Hassan M, Hassany M, Hutton D, Irmansyah I, Jancoriene L, Kirwan J, Kumar S, Lennon P, Lopardo G, Lydon P, Magrini N, Maguire T, Manevska S, Manuel O, McGinty S, Medina MT, Mesa Rubio ML, Miranda-Montoya MC, Nel J, Nunes EP, Perola M, Portolés A, Rasmin MR, Raza A, Rees H, Reges PPS, Rogers CA, Salami K, Salvadori MI, Sinani N, Sterne JAC, Stevanovikj M, Tacconelli E, Tikkinen KAO, Trelle S, Zaid H, Røttingen JA, Swaminathan S. Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results. N Engl J Med. 2021 Feb 11;384(6):497-511. doi: 10.1056/NEJMoa2023184. Epub 2020 Dec 2.
Guimarães PO, Quirk D, Furtado RH, Maia LN, Saraiva JF, Antunes MO, et al. Tofacitinib in Patients Hospitalized with Covid-19 Pneumonia. 2021.

Other Publications:
NIH closes enrollment in trial comparing COVID-19 treatment regimens: National Institutes of Health 2021 [updated April 15. Available from: https://www.nih.gov/news-events/news-releases/nih-closes-enrollment-trial-comparing-covid-19-treatment-regimens.
Natanegara F, Zariffa N, Buenconsejo J, Ran L, Cooner F, Lakshminarayanan D, et al. Statistical Opportunities to Accelerate Development for COVID-19 Therapeutics. Statistics in Biopharmaceutical Research. 2020:1-17.
COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed [29/05/2021].

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Responsible Party: Wasim Md Mohosin Ul Haque, Associate Professor, Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
ClinicalTrials.gov Identifier: NCT04970719    
Other Study ID Numbers: BADAS-ERC/EC/21/00311
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: relative to the time when summary data are published
Access Criteria: all data will be available if required

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wasim Md Mohosin Ul Haque, Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders:
COVID-19
baricitinib
remdesivir
dexamethasone
diabetes mellitus
hospitalized
Additional relevant MeSH terms:
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Diabetes Mellitus
Pneumonia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Dexamethasone
Janus Kinase Inhibitors
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action