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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: Tramadol Other: Standard care delivered in the isolation hospitals. | Phase 1 Phase 2 |
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 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 |

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 |
- Number of COVID-19 PCR negative cases [ Time Frame: 10 days ]PCR analysis of nasal swabs from COVID-19 patients

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

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
Contact: Nahla Elashmawy, PhD | 201116721982 | nahla.elashmawi@pharm.tanta.edu.eg |
Principal Investigator: | Nahla Elashmawy, PhD | Tanta University |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 |
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 |