Telmisartan for Treatment of COVID-19 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: NCT04355936|
Recruitment Status : Completed
First Posted : April 21, 2020
Last Update Posted : December 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Drug Treatment||Drug: Telmisartan arm will receive 80 mg Telmisartan twice daily plus standard care.||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized to receive standard care or standard care plus Telmisartan 80 mg twice daily upon diagnosis of COVID-19.|
|Masking:||None (Open Label)|
|Official Title:||Telmisartan for Treatment of COVID-19 Patients: an Open Label Randomized Trial|
|Actual Study Start Date :||May 19, 2020|
|Actual Primary Completion Date :||November 2, 2020|
|Actual Study Completion Date :||November 30, 2020|
Patients in this group will receive 80 mg Telmisartan twice daily plus standard care.
Drug: Telmisartan arm will receive 80 mg Telmisartan twice daily plus standard care.
Control arm will receive standard care.
No Intervention: CONTROL
Patients in this group will receive standard care.
- C reactive protein [ Time Frame: Days 5 and 8 after enrollment ]Serum C rective protein levels
- Admission to intensive care unit (ICU) [ Time Frame: Within 15 and 30 days after randomization ]
- Occurrence of mechanical ventilation [ Time Frame: Within 15 and 30 days after randomization ]
- Death [ Time Frame: Within 15 days and 30 days ]All-cause mortality; and time to all-cause mortality
- Composite occurrence of admission to ICU, mechanical ventilation or death (what occur first) [ Time Frame: Within 15 and 30 days after randomization ]
- Time from randomization to discharge [ Time Frame: Within 15 days ]
- Proportion of patients not requiring supplemental oxygen at day 15 [ Time Frame: Within 15 days ]
- Significative differences in serum lactate dehydrogenase [ Time Frame: Days 5 and 8 ]Troponin serum levels
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): NCT04355936
|Hospital de Clínicas 'José de San Martín', Facultad de Medicina, Universidad de Buenos Aires|
|Buenos Aires, Ciudad De Buenos Aires, Argentina, C1120AAR|
|Hospital Español de Buenos Aires|
|Ciudad Autonoma de Buenos Aires, Argentina, 1209|
|Study Chair:||Francisco Azzato, MD||Department of Internal Medicine, Hospital de Clínicas 'José de San Martín', Facultad de Medicina, Universidad de Buenos Aires|
|Principal Investigator:||Mariano Duarte, MD||Hospital de Clínicas 'José de San Martín', Universidad de Buenos Aires|