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Treatment of Sars-CoV2 infections (Covid-19) with valsartan vs placebo, a three-armed randomized, partly blinded trial

Organizational Data

DRKS-ID:
DRKS00021732
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2020-06-10
Last update in DRKS:
2020-11-09
Registration type:
Prospective

Acronym/abbreviation of the study

CovidVal01

URL of the study

http://www.covidval.de

Brief summary in lay language

The COVIDAL trial includes the randomized switch from ACE inhibitors to angiotensin receptor blockers (ARBs) and the use of ARBs versus placebo for SARS-COV-2 infection. The background to this study is unconfirmed speculation about the effect of ACE inhibitors and ARBs in Covid-19. These drugs should not be discontinued out of speculative caution. However, there are well-founded mechanistic considerations that ARBs are more useful than ACE inhibitors in terms of their Covid-19 effect, while having the same efficacy against hypertension, heart and kidney failure. Therefore, by switching from ACE inhibitors to ARBs or adjusting to ARBs, the relationship between these drugs and corona infection is being investigated. The aim is to analyse which individual patients could benefit from switching from ACE inhibitors or adjusting to ARBs.

Brief summary in scientific language

Since there is no drug therapy available to treat the currently pandemic SARS-Cov2 virus, available therapeutic principles must be examined for their suitability. Due to the interrelationship of the virus entry mechanism with the ACE 2 receptor, there are complex considerations on the efficacy and speculations on the harmfulness of ACE inhibitors and angiotensin receptor blockers. Due to the highly evident effects in renovascular and cardiovascular diseases, such drugs should not be discontinued out of speculative caution. There are, however, well-founded mechanistic considerations that, while having the same efficacy in the reno- and cardiovascular area, angiotensin receptor blockers rather do not involve lung damage and covid-19 acceleration. Therefore, a controlled trial will be conducted, which includes the randomized switch from ACE inhibitors to angiotensin receptor blockers in pretreated patients and the use of angiotensin receptor blockers de novo versus placebo in patients not previously treated with ACE inhibitors or angiotensin receptor blockers. All patients with positive SARS-COV2 detection should be included. The patient integration will be done digitally via a messenger system. The randomized test medication will be sent by post to outpatients. Inpatients will be treated by the study department of the trial site during their stay.

Health condition or problem studied

Free text:
Covid-19
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Patients not pretreated with ACE inhibitors or AT1 antagonists: Valsacor 80 mg 1-0-1 (target dose if well tolerated, starting dose 0-0-1) vs. P-tablets Lichtenstein white 1-0-1 (target dose if well tolerated, starting dose 0-0-1)
Arm 2:
Patients pretreated with ACE inhibitors: Valsacor 80 mg 1-0-1 (target dose if well tolerated, starting dose: equivalent of previous medication with ACE inhibitor) vs. ramipril 5 mg (or equivalent) 1-0-0 (target dose if well tolerated, starting dose: previous ACE inhibitor medication or ramipril equivalent)
Arm 3:
Patients pretreated with AT1 antagonists: Valsacor 80 mg (or equivalent) 1-0-1 (target dose with good tolerability, starting dose: previous AT1 antagonist medication or valsartan equivalent)

Endpoints

Primary outcome:
combined clinical improvement (7-category ordinal scale of clinical Status or Hospital discharge), daily assessment
Secondary outcome:
Secondary endpoints are collected post-hoc according to the availability of routine data. Mainly respiratory indices (Horovitz), virus load or PCR results, ventilation frequency, duration of hospitalisation and death are considered

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
  • Placebo
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Investigator/therapist
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Medical center Klinikum St. Georg gGmbH Leipzig

Recruitment period and number of participants

Planned study start date:
2020-06-14
Actual study start date:
2020-06-30
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
300
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
- Patients aged over 18 years with given consent, first positive Sars-Cov2 detection within the last three days - Patients with pre-existing chronic renal insufficiency in any degree of severity - Patients of both gender

Exclusion Criteria

- intolerance to RAS-I and ARB - Contraindications against ACE/ARB according to current clinical standard - History of falls (more than 2 falls in the last 8 weeks) - Symptomatic hypotension (i.e. blood pressure < 100 mmHg systolic and/or 50 mmHg diastolic together with hypotensive symptoms) - Acute renal failure from stage 2 - pregnancy

Addresses

Primary Sponsor

Klinikum St. Georg gGmbH
Delitzscher Straße 141
04129 Leipzig
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinikum St. Georg gGmbH, Klinik für Infektiologie/Tropenmedizin, Nephrologie und Rheumatologie
Prof. Dr. Joachim Beige
Delitzscher Str. 141
04129 Leipzig
Germany
Telephone:
03419094056
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Klinikum St. Georg gGmbH, Klinik für Infektiologie/Tropenmedizin, Nephrologie und Rheumatologie
Prof. Dr. Joachim Beige
Delitzscher Str. 141
04129 Leipzig
Germany
Telephone:
03419094056
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Klinikum St. Georg gGmbH, Klinik für Infektiologie/Tropenmedizin, Nephrologie und Rheumatologie
Prof. Dr. Joachim Beige
Delitzscher Str. 141
04129 Leipzig
Germany
Telephone:
03419094056
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Klinikum St. Georg gGmbH
Delitzscher Straße 141
04129 Leipzig
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Sächsische Landesärztekammer Ethikkommission
Schützenhöhe 16
01099 Dresden
Germany
Telephone:
+49-351-8267333
Fax:
+40-351-8267332
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2020-03-27
Ethics committee number:
EK-AMG-MO-1/20-1
Vote of the Ethics Committee:
Approved
Date of the vote:
2020-04-20

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
2020-001431-27
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry