NCT04433988

Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients

Withdrawn Phase 1, PHASE2 Last updated 18 January 2023

What this trial tests

Phase 1, PHASE2 trial testing Pentoxifylline in COVID. Withdrawn.

Timeline

13 November 2022

Primary endpoint
30 December 2022

30 December 2022

Quick facts

Lead sponsor	Sadat City University
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Start date	13 November 2022
Primary completion	30 December 2022
Estimated completion	30 December 2022
Sites	1 location across Egypt

Drugs / interventions tested

• Pentoxifylline — full drug profile →
• Placebo

Conditions studied

• COVID — all drugs for COVID →

Sponsor

Sadat City University

Who can join

Adults 18 to 60, any sex, with COVID. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting Neutrophils to Treat Acute Respiratory Distress Syndrome in Coronavirus Disease.
   Chiang CC, Korinek M, Cheng WJ, Hwang TL. · · 2020 · cited 97× · PMID 33162887 · DOI 10.3389/fphar.2020.572009
2. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
   Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
3. Cell deaths: Involvement in the pathogenesis and intervention therapy of COVID-19.
   Li X, Zhang Z, Wang Z, Gutiérrez-Castrellón P, et al · · 2022 · cited 58× · PMID 35697684 · DOI 10.1038/s41392-022-01043-6
4. Host metabolic reprogramming in response to SARS-CoV-2 infection: A systems biology approach.
   Moolamalla STR, Balasubramanian R, Chauhan R, Priyakumar UD, et al · · 2021 · cited 58× · PMID 34333072 · DOI 10.1016/j.micpath.2021.105114
5. The role of cell death in SARS-CoV-2 infection.
   Yuan C, Ma Z, Xie J, Li W, et al · · 2023 · cited 51× · PMID 37726282 · DOI 10.1038/s41392-023-01580-8
6. Phosphodiesterase Inhibitors in Acute Lung Injury: What Are the Perspectives?
   Mokra D, Mokry J. · · 2021 · cited 38× · PMID 33669167 · DOI 10.3390/ijms22041929
7. Commonalities Between COVID-19 and Radiation Injury.
   Rios CI, Cassatt DR, Hollingsworth BA, Satyamitra MM, et al · · 2021 · cited 24× · PMID 33064832 · DOI 10.1667/rade-20-00188.1
8. The role of reactive oxygen species in severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection-induced cell death.
   Xie J, Yuan C, Yang S, Ma Z, et al · · 2024 · cited 14× · PMID 39516736 · DOI 10.1186/s11658-024-00659-6