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Investigating the Role of 13cis Retinoic Acid in the Treatment of COVID-19 and Enhancement of Its Spike Protein Based Vaccine Efficacy and Safety.

NCT04730895 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2021-06-02

No results posted yet for this study

Summary

Investigating the role of 13cis retinoic acid in the treatment of COVID-19 and enhancement of Its spike protein based vaccine efficacy and safety.

Conditions

  • Covid19 Vaccine

Interventions

DRUG

Oral 13 cis retinoic acid

Dose of 0.5 mg/kg/day in 2 divided doses orally for 14 days

DRUG

Aerosolized 13 cis retinoic acid

Dose of Aerosolized 13 cis retinoic acid in gradual in 2 divided doses increases froms 0.2 mg/kg/day to 4 mg/kg/day

COMBINATION_PRODUCT

13 cis retinoic acid doses orally in combination with spike protein based vaccine

Dose of 13 cis retinoic acid (0.5 mg/kg/day in 2 divided doses orally for 14 days and also, participants will receive two doses of 5-7.5x10\^10 vp spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine in deltoid of non-dominant arm, 28 days apart

COMBINATION_PRODUCT

Aerosolized 13 cis retinoic acid in combination with spike protein based vaccine

Dose of Aerosolized 13 cis retinoic acid in gradual in 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day for 14 days and also, participants will receive two doses of 5-7.5x10\^10 vp spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine in deltoid of non-dominant arm, 28 days apart

BIOLOGICAL

Biological: spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine

Dose of 5-7.5x10\^10vp of spike protein based vaccine such as ChAdOx1 nCoV-19 in deltoid of non-dominant arm, 28 days apart

Sponsors & Collaborators

  • Kafrelsheikh University

    lead OTHER

Principal Investigators

  • Mahmoud Elkazzaz, M.Sc in Biochemistry · Facculty of Science, Damietta University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-31
Primary Completion
2021-09-30
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04730895 on ClinicalTrials.gov