Status: Planned First registered on: 28/03/2020
Last updated on: 05/08/2020
1. Study identification
EU PAS Register NumberEUPAS34331
Official titleCASE AND CONTROLS NESTED IN AN AMBISPECTIVE COHORT TO EVALUATE THE EFFECT OF CO-MEDICATION ON THE EVOLUTION OF SARS-CoV-2 CORONAVIRUS INFECTION (COVID-19)
Study title acronymHULP-COVID19-ACE2-20
Study typeObservational study
Brief description of the studyThere is evidence that SARS-CoV-2 binds to the cellular ACE2 receptor to inoculate itself, which calls into question the use of drugs that may have an impact on the renin-angiotensin-aldosterone axis by increasing the probability of acquiring the infection. Most of the works maintain that it can favor the virus entering the body, although there is much controversy with the withdrawal or maintenance of drugs that intervene or collaterally affect this axis, since there are authors who argue that SARS-CoV -1 down-regulates ACE2 and increasingly ACE, and this can damage lung tissue, favoring the appearance of SARS. This can carry over to SARS-CoV-2 because of its genetic similarity to the former. Therefore, it is necessary to know whether withdrawal or maintenance or certain medication or vaccines are risk factors or increase the probability of a good evolution. For this last reason, we propose the present study.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsClinical Pharmacology Department, HULP, UAM
Department/Research groupClinical Pharmacology Department
Organisation/affiliationHospital La Paz, School of Medicine, UAM
Website/Homepage
Details of (Primary) lead investigator
Title Dr
Last name Ramirez
First name Elena
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

Clinical Pharmacology Department, HULP, UAM
Clinical Pharmacology Service HUPHM
H. UL la Princesa, Madrid, Spain
Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed19/03/2020
Start date of data collection23/03/2020
Start date of data analysis30/06/2020
Date of interim report, if expected31/07/2020
Date of final study report31/08/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherOwn funding100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Ramirez
First name Elena
Address line 1Servicio de Farmacología Clínica
Address line 2Hospital Universitario la Paz 
Address line 3Paseo de la Castellana 261 
CityMADRID 
Postcode28046 
CountrySpain
Phone number (incl. country code)34-91-7277559 
Alternative phone number34-619505586 
Fax number (incl. country code)34-91-7277559 
Email address elena.ramirezg@uam.es
Public Enquiries
Title Dr 
Last name Ramirez 
First name Elena 
Address line 1Servicio de Farmacología Clínica 
Address line 2Hospital Universitario la Paz 
Address line 3Paseo de la Castellana 261 
CityMADRID 
Postcode28046 
CountrySpain 
Phone number (incl. country code)34-91-7277559 
Alternative phone number34-619505586 
Fax number (incl. country code)34-91-7277559 
Email address elena.ramirezg@uam.es 
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