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| Column | Value |
|---|---|
| Trial registration number | NCT04340544 |
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Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Nov. 3, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Nov. 3, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
diane.egger-adam@uni-tuebingen.de |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-09 |
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Recruitment status
Last imported at : Nov. 3, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Terminated |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - must be ≥18 years at the time of signing the informed consent - understand and voluntarily sign an informed consent document prior to any study related assessments/procedures - able to adhere to the study visit schedule and other protocol requirements - mild covid-19 with outpatient management as decided by the treating physician - early warning score for 2019-ncov infected patients ≤ 5 - females of childbearing potential (fcbp1) must agree - to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe - to abstain from breastfeeding during study participation and 28 days after study drug discontinuation - all subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment - all subjects must agree not to share medication |
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- requirement for oxygen administration - shortness of breath in resting position - creatinin > 2.0 mg/dl - women during pregnancy and lactation - participation in other clinical trials or observation period of competing trials - active or clinically significant cardiac disease including congestive heart failure (new york heart association class iii or higher) - history or current evidence of clinically significant cardiac arrhythmia except atrial fibrillation or paroxysmal supraventricular tachycardia - use of concomitant medications that prolong the qt/qtc interval - physician decision that involvement in the study is not in the patient´s best interest |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
University Hospital Tuebingen |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
99 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Germany |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
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Total sample size
Last imported at : Nov. 3, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
17 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Difference in time to resolution of clinical signs and symptoms of mild COVID-19 treated with hydroxychloroquine or placebo as assessed by daily self-assessment |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Results available at https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001512-26/results", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Results available at https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001512-26/results", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |