Safety and Efficacy of Tramadol in COVID-19 Egyptian Patients

NCT04454307 | Unknown Phase 1 DMC

• 1 other identifier: TRAM/COVID19
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The rationale of the use of tramadol for COVID-19 patients is attributed to its anti-inflammatory, hypocagulatory, antioxidant, cardio-protective, analgesic, antitussive, bactericidal and antidepressant effect.

Conditions

COVID-19

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of COVID-19 PCR negative cases

  PCR analysis of nasal swabs from COVID-19 patients

  10 days

Study Arms (2)

Tramadol

EXPERIMENTAL

tramadol 100 mg twice daily for 10 days

Drug: Tramadol

standard care

ACTIVE COMPARATOR

standard care plus (placebo twice daily for 10 days).

Other: Standard care delivered in the isolation hospitals.

Interventions

Tramadol DRUG

tramadol 100 mg twice daily for 10 days

Also known as: tramal

Tramadol

Standard care delivered in the isolation hospitals. OTHER

Oxygen ventilation.

Also known as: nasal oxygen

standard care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed symptomatic COVID-19 patients with mild to moderate respiratory manifestations, adults (18-65 Years old), and both sexes.

You may not qualify if:

• Patients with abnormal liver function (ALT, AST), chronic kidney disease or dialysis (CrCl\< 30 ml/min)
• Pregnant women or women who are breastfeeding
• Immunocompromised patients taking medication upon screening
• Subjects with comorbid condition like hypertension, cardiovascular disease, diabetes mellites, asthma, COPD, malignancy
• Patients having allergy to Hydroxychloroquine and/or Nitazoxanide
• Patients with contraindication towards the study medication including retinopathy, G6PD deficiency and QT prolongation.

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Conditions

COVID-19

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Nahla Elashmawy, PhD

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nahla Elashmawy, PhD

CONTACT

201116721982; nahla.elashmawi@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: A randomized Double Blind Controlled Clinical Trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Faculty of Pharmacy

Model Details: A randomized Double Blind Controlled Clinical Trial

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 1, 2020
• Study Start: July 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: October 1, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share