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Safety and Efficacy of Tramadol in COVID-19 Egyptian 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04454307
Recruitment Status : Unknown
Verified June 2020 by Prof. Dr. Nahla El-Ashmawy, Tanta University.
Recruitment status was:  Not yet recruiting
First Posted : July 1, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Nahla El-Ashmawy, Tanta University

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Tramadol Other: Standard care delivered in the isolation hospitals. Phase 1 Phase 2

Detailed Description:

Background and Rationale:

T cells play a critical role in antiviral immunity, their level was dramatically reduced in COVID-19 patients. There is a negative correlation between T cell numbers and cytokines serum level in COVID-19 patients. In those patients, there is up-regulation of inflammatory cytokines including interleukin (IL)-1, IL-6, tumor necrosis factor (TNF)-α, and interferon γ. This makes the use of tramadol reasonable in such patients because it has anti-inflammatory effect decreasing plasma level of TNF-α after treatment with a dose of 100 mg every 12 hours for 10 days, which may result in a subsequent increase in T cell numbers.

Besides, COVID-19 patients with acute respiratory failure present with severe hypercoagulability due to hyperfibrinogenemia resulting in increased fibrin formation and polymerization that may predispose to thrombosis. It has been reported that tramadol has a hypocoagulable effect in the blood of women with gynecologic malignancies. Consequently, tramadol may be useful for patients who have a tendency toward a hypercoagulable status and thromboembolic complications. Moreover, tramadol could affect hemostatic parameters in favor of bleeding tendency in rats.

On the other hand, the severity and mortality risk of COVID-19 have been associated with the age. This age-related mortality is attributed to the shortage of antioxidant mechanisms and increased oxidative damage. Tramadol increased the antioxidant enzymes superoxide dismutase and glutathione peroxidase while diminished the oxidative stress marker malondialdehyde in testicular ischemia-reperfusion injury in rats. Owing to its antioxidant properties, tramadol could reduce complications in COVID-19 patients.

Moreover, tramadol was reported to significantly lower lactate dehydrogenase (LDH) level and to provide a cardio-protective effect. This property of tramadol seems beneficial since it was found that, about 60% of COVID-19 patients are presented with elevated LDH levels. Tramadol has also antitussive property. Tramadol is a unique analgesic offering moderate, dose-related pain relief through its action at multiple sites. In contrast to pure opioid agonists, it has a low risk of respiratory depression, tolerance, and dependence. Previous studies confirmed that tramadol dependence may occur when it is used daily for more than a few weeks/months.

More interestingly, patients infected with COVID-19 may experience intense emotional and behavioral reactions, such as fear, loneliness, anxiety, insomnia, or anger. These conditions can be especially prevalent in quarantined patients. Tramadol is a centrally acting analgesic drug with a dual mechanism of action: binding to μ-opioid receptors and the inhibition of serotonin and norepinephrine reuptake. Through its ability to inhibit serotonin and norepinephrine reuptake, tramadol may exhibit antidepressant activity. In this context, the analgesic and antidepressant effects of tramadol may favor its use for COVID-19 patients. Tramadol also was found to have dose- and time-dependent bactericidal activity against Escherichia coli, Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas aeruginosa pathogens in vitro.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized Double Blind Controlled Clinical Trial
Masking: Double (Participant, Care Provider)
Masking Description: A randomized Double Blind Controlled Clinical Trial
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Tramadol Adjuvant Therapy to Standard Care for COVID-19 Egyptian Patients: A Randomized Double Blind Controlled Clinical Trial
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tramadol
tramadol 100 mg twice daily for 10 days
 Drug: Tramadol
tramadol 100 mg twice daily for 10 days
Other Name: tramal
Active Comparator: standard care
standard care plus (placebo twice daily for 10 days).
 Other: Standard care delivered in the isolation hospitals.
Oxygen ventilation.
Other Name: nasal oxygen


Outcome Measures
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Primary Outcome Measures :
  1. Number of COVID-19 PCR negative cases [ Time Frame: 10 days ]
    PCR analysis of nasal swabs from COVID-19 patients


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Contacts and Locations
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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): NCT04454307


Contacts
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Contact: Nahla Elashmawy, PhD 201116721982 nahla.elashmawi@pharm.tanta.edu.eg

Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Nahla Elashmawy, PhD Tanta University
More Information
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Responsible Party: Prof. Dr. Nahla El-Ashmawy, Dean of Faculty of Pharmacy, Tanta University
ClinicalTrials.gov Identifier: NCT04454307    
Other Study ID Numbers: TRAM/COVID19
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Prof. Dr. Nahla El-Ashmawy, Tanta University:
COVID-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents