Objective: To assess whether angiotensin receptor blocker (ARB) use is beneficial in the early phase of the disease, to prevent lung oedema and damage in high risk patients with a proven COVID-19 infection.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study endpoints: The primary outcome for this study is a combination of death
or hospital admission after 30 days.
Secondary outcome
Secondary outcomes are time to reduce symptoms, such as fever, cough and
dyspnoe after 30 days.
Background summary
Recent research concerning the covid-19 virus causing a pandemic suggests that
angiotensin-receptor blocking therapy could be clinically beneficial for
Covid-19 infected patients, especially in an early phase. AT1R blockage by ARB
therapy could be able to prevent the elevated angiotensine II expression, which
is responsible for lung edema and damage in infected patients.
Study objective
Objective: To assess whether angiotensin receptor blocker (ARB) use is
beneficial in the early phase of the disease, to prevent lung oedema and damage
in high risk patients with a proven COVID-19 infection.
Study design
Study design: The Lock-covid-19 study is an open-label randomized controlled
trial assessing the effect of ARB in an early phase on high risk covid-19
patients to prevent hospital admission and death, as compared to conventional
therapy.
Intervention
Intervention: The intervention consists of Telmisartan 160 mg once daily, taken
orally for 14 days. preceded by a 2 test doses, 12 hours apart.
Study burden and risks
Patients allocated to the interventional group will receive Telmisartan
following standard practice in clinical setting for hypertension treatment.
Common side effects are dizziness, headache, nausea and/or vomiting, cough,
hyperkalaemia and hypotension. Liver and/or kidney failure, leukopenia and
angioedema are severe, yet rare, side effects. Registered interactions of ARB*s
are fluconazole, rifamycin and drugs elevating the potassium level. Since
Covid-19 is a relatively new virus, we have yet to discover most of the
etiology and physiology of the virus. Therefore, we cannot foresee any
interactions or side effects for Covid-19 patients specifically.
meibergdreef 9
Amsterdam 1102 AZ
NL
meibergdreef 9
Amsterdam 1102 AZ
NL
Listed location countries
Age
Inclusion criteria
- Age * 70 years of age or comorbidities such as chronic lung disease,
cardiovascular disease, any solid or haematological malignancies, diabetes,
hypertension, rheumatic disease, immune-deficiencies either by disease or by
medication use or severe obesity (BMI * 35).
- Fever (a temperature of * 38,0 °C) or complaints of cough with or without
dyspnoea
- AND at least one of these symptoms typical for SARS-CoV-2 infection such as:
o fatigue
o myalgia
o headache
o nausea, vomiting and diarrhoea
o loss of smell and/or taste.
- Positive PCR test or High suspicion of a SARS-COV-2 infection because of
typical symptoms and the possibility that the individuals could have been
infected.
- Being able to give written or verbal informed consent
Exclusion criteria
- Suffering from (symptomatic) hypotension
- Registered allergy to Telmisartan.
- Receiving Potassium supplement.
- Renal failure requiring dialysis therapy or (previous) kidney transplant
- Known liver disease or liver insufficiency
- Inability to comprehend patient information due to mental impairment such as
dementia.
- life expectancy of less than 3 months
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-002343-32-NL |
| CCMO | NL74029.018.20 |