Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients
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Patrocinadores
Sadat City University
ENSAYO CLÍNICO: NCT04433988
BioSeek: nct04433988
Palabras clave
Abstracto
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.
fechas
| Verificado por última vez: | 06/30/2020 |
| Primero enviado: | 06/12/2020 |
| Inscripción estimada enviada: | 06/12/2020 |
| Publicado por primera vez: | 06/15/2020 |
| Última actualización enviada: | 07/01/2020 |
| Última actualización publicada: | 07/06/2020 |
| Fecha de inicio real del estudio: | 08/12/2020 |
| Fecha estimada de finalización primaria: | 12/29/2020 |
| Fecha estimada de finalización del estudio: | 12/29/2020 |
Condición o enfermedad
COVID
Intervención / tratamiento
Drug: Pentoxifylline group
Drug: Control group
Fase
Fase 1/Fase 2
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Placebo Comparator: Control group 100 patients will receive standard treatment plus placebo | Drug: Control group Placebo tablet |
| Experimental: Pentoxifylline group 100 patients will receive standard treatment plus pentoxifylline 1200 mg/day | Drug: Pentoxifylline group Pentoxifylline 400 mg SR tablet |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Positive COVID-19 test - Age >/= 18 y.o. Exclusion Criteria: - Allergic reaction to Pentoxifylline - Ongoing anticoagulation - History of GI bleeding - History of Seizures - Cardiac or other vascular stents - History of severe renal disease - History of intracranial hemorrhage. |
Salir
Medidas de resultado primarias
1. Primary Outcome [7 days]
Number of Participants need hospitalization
Medidas de resultado secundarias
1. Respiratory infection [7 days]
Incidence of any acute respiratory infection
2. Serious Adverse Events [7 days]
Absolute and relative frequencies of Serious Adverse Events
