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Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients

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: NCT04433988
Recruitment Status : Not yet recruiting
First Posted : June 16, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Mahmoud Samy Abdallah, Sadat City University

Tracking Information
First Submitted Date  ICMJE June 13, 2020
First Posted Date  ICMJE June 16, 2020
Last Update Posted Date January 5, 2021
Estimated Study Start Date  ICMJE June 13, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2020)		 Primary Outcome [ Time Frame: 7 days ]
Number of Participants need hospitalization
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2020)		 Primary Outcome [ Time Frame: 7 days ]
a need for hospitalization
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2020)
  • Respiratory infection [ Time Frame: 7 days ]
    Incidence of any acute respiratory infection
  • Serious Adverse Events [ Time Frame: 7 days ]
    Absolute and relative frequencies of Serious Adverse Events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients
Official Title  ICMJE Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients
Brief Summary With potential antiviral effects on severe acute respiratory syndrome (SARS) and as a methyl-xanthine derived inhibitor of phosphodiesterase-4, pentoxifylline basically functions as a hemorrheologic agent for a better circulation and oxygenation and exerts unique effects on immune modulation, inflammation and oxidative stress. As the main regulator of cAMP metabolism, posphodiesterase-4 plays a key role in proinflammatory and immune cells. Pentoxifylline plays its anti-inflammatory role by reducing the production of proinflammatory cytokines such as TNF-a, IL-1 and IL-6. Given its unique impacts on immune modulation, homeostasis and fibrinolysis and its supportive effects on oxidative stress and organ failure, pentoxifylline can constitute a multipurpose and generally-safe adjuvant therapy for COVID-19 patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID
Intervention  ICMJE
  • Drug: Pentoxifylline
    Pentoxifylline 400 mg SR tablet
  • Drug: Placebo
    Placebo tablet
Study Arms  ICMJE
  • Placebo Comparator: Control group
    100 patients will receive standard treatment plus placebo
    Intervention: Drug: Placebo
  • Experimental: Pentoxifylline group
    100 patients will receive standard treatment plus pentoxifylline 1200 mg/day
    Intervention: Drug: Pentoxifylline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2020)		 200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Positive COVID-19 test
  • Age >/= 18 y.o.

Exclusion Criteria:

  • Allergic reaction to Pentoxifylline
  • Ongoing anticoagulation
  • History of GI bleeding
  • History of Seizures
  • Cardiac or other vascular stents
  • History of severe renal disease
  • History of intracranial hemorrhage.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mahmoud S Abdallah, PhD 00201063340887 Mahmoud.samy@fop.usc.edu.eg
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04433988
Other Study ID Numbers  ICMJE RC-6-2020
Has Data Monitoring Committee Yes
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  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Responsible Party Mahmoud Samy Abdallah, Sadat City University
Study Sponsor  ICMJE Sadat City University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sadat City University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP