Demonstrate that iodine treatment has a beneficial effect on the course of COVID-19 disease. Beneficial effect is defined as less critically relevant deterioration such as transfers from regular to intensive care units, fewer days of hospitalization…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinically relevant deterioration defined as:
1. transfer from regular ward to IC department
2. death in regular ward depatment
3. death in IC department
Secondary outcome
Total number of days in hospital and total number of deaths.
Background summary
Iodine has a germicidal effect and contributes to the defense mechanism against
pathogens. In addition, Iodine has anti-inflammatory, immune modulating
properties and is a very potent scavenger of free oxygen radicals. These
properties may have a beneficial effect on the treatment of COVID-19
infections. Several case reports describe a beneficial effect of iodine
treatment in viral infections.
Epidemiological research into the number of deceased COVID-19 patients found a
striking difference between Japan and Italy. On April 1, 2020, Japan will have
57 deaths with 126 million inhabitants (0.5 / million) and Italy 12,428 deaths
with 60 million inhabitants (207 / million). Furthermore, the Japanese are
known for their high iodine intake through food, in contrast to Italians who
are iodine deficient. The iodine status, measured in Urine Iodine Concentration
(UIC) according to the WHO criteria, is 282 mcg / L in Japan and 84 mcg / L in
Italy.
The immuno-physiological properties of iodine, the case reports and the
epidemiological data suggest a protective effect of iodine against COVID-19
infections. This leads to our hypothesis that iodine is effective in treating
COVID-19 infections. To test the hypothesis, we want to investigate the
treatment of iodine in COVID-19 infected patients.
All patients over 18 years of age who are enrolled in Maxima MC are asked to
participate in the study.
Exclusion criteria: history of treatment with radioactive iodine, goiter, use
of thyroid medication or amiodarone and incapacitation.
The following patient characteristics are collected: age, gender, height,
weight, comorbidity, smoking and medication use.
Patients are randomized with the intervention and control group equally divided.
Patients in the intervention group receive 3 dd 6 mg (1,5 mg/ml Potassium
Jodide) iodine solution for 5 days.
The control group is not given a placebo supplement.
Outcome measures are:
Primary: clinically relevant deterioration defined as transfer from regular
nursing unit to intensive care unit or death.
Secondary: total number of days in hospital and total number of deaths.
In addition, the cumulative amount of iodine used per patient is registered and
other medication used in the context of the COVID-19 infection.
Study objective
Demonstrate that iodine treatment has a beneficial effect on the course of
COVID-19 disease. Beneficial effect is defined as less critically relevant
deterioration such as transfers from regular to intensive care units, fewer
days of hospitalization and less death.
Study design
Open label randomized trial with a control group.
Intervention
Patients in the intervention group receive 1 dd 1/4 PotassiumJodide 65 mg
tablet for 8 days.
The control group is not given a placebo supplement.
Study burden and risks
the inconvenience of taking 1 dd 1/4 PotassiumJodide 65 mg tablet for 8 days is
negligible.
Risk of side effects are minimale en temporary.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
Hospitalization and positive test for SARS-CoV-2 infection
Exclusion criteria
Thyroid disease or treatment like goiter, thyroidectomie, radioactive iodine,
medication related to thyroid dysfunction or the use of Amiodaron
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2020-001852-16-NL |
CCMO | NL73784.028.20 |
OMON | NL-OMON25013 |
OMON | NL-OMON26738 |