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Toclizumam Versus Dexamethasone in Severe Covid-19 Cases

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: NCT04519385
Recruitment Status : Completed
First Posted : August 19, 2020
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Alaa Rashad, South Valley University

Brief Summary:
randomized controlled trial comparing survival benefit of Tocilizumab therapy with dexamethasone in patients with severe COVID 19

Condition or disease Intervention/treatment Phase
Pneumonia, Viral Drug: Tocilizumab Drug: Dexamethasone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: dexamethsone group Tocilizumab group
Masking: Double (Participant, Outcomes Assessor)
Masking Description: single blind
Primary Purpose: Treatment
Official Title: Toclizumam Versus Dexamethasone in Severe Covid-19 Cases
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : August 5, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tocilizumab
Tocilizumab
Drug: Tocilizumab
Tocilizumab therapy
Other Name: TCZ

Active Comparator: Dexamethasone
Dexamethasone therapy
Drug: Dexamethasone
dexamethsone pulse therapy
Other Name: dexamethsone pulse therapy




Primary Outcome Measures :
  1. Proportion of participants with Overall Survival at 14 days [ Time Frame: 14 days ]
    survival 14 days from admission date


Secondary Outcome Measures :
  1. Fio2/Pao2 [ Time Frame: 2 days ]
    Change in Fio2/Pao2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • respiratory rate > 30 cycle/minute, Bilateral CT infiltration > 30%, PaO2/FiO2 ratio <150 or saturation <90 on >6L/min, Two positive laboratory tests of: (CRP>100 g/dL, lymphocytes<600 /mm3, D dimer>L, Ferritin >500)

Exclusion Criteria:

  • Pediatric patients < 18 years old, patients with active bacterial or fungal infection and patients who were not requiring supplemental oxygen

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): NCT04519385


Locations
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Egypt
Qena faculty medicine
Qinā, Egypt, 83523
Sponsors and Collaborators
South Valley University
Investigators
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Principal Investigator: Alaa R rashad, MD South Valley University
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Responsible Party: Alaa Rashad, Assistant professor, South Valley University
ClinicalTrials.gov Identifier: NCT04519385    
Other Study ID Numbers: SouthVU
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020

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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 Alaa Rashad, South Valley University:
COVID19
Tocilizumab
dexamethsone
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Dexamethasone
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