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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04371952 |
|
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 : April 21, 2022, 1 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : April 21, 2022, 1 a.m. Source : ClinicalTrials.gov |
not reported |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-05-01 |
|
Recruitment status
Last imported at : April 21, 2022, 1 a.m. Source : ClinicalTrials.gov |
Withdrawn |
|
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 |
multi-center |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - man or woman > 45 years old. - patient with a positive sars-cov-2 pcr - patient with ent and / or respiratory symptoms, without hospitalization criteria (no dyspnea, respiratory rate <22 / min, sao2 ≥ 94% in ambient air), or digestive signs. - patient with at least one of the following risk factors for unfavorable outcome: - 70 years, bmi> 30, cardiovascular history (stroke, coronary artery disease, complicated hypertension, cardiac surgery, nyha iii or iv heart failure), respiratory pathology likely to decompensate during viral infection respiratory failure, unbalanced and / or complicated diabètes, respiratory pathology likely to decompensate in the event of of viral infection, patients with renal insufficiency chronic dialysis, .cancer patients under treatment. |
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- lactose-intolerant patients - patient needing immediate hospitalization for any medical reason - patient having more than 5 days of clinical symptoms at the inclusion visit - patients with a history of allergy to tetracyclines - pregnant or lactating women - patients participating in another clinical trial - patients with photosensitive skin pathology - patients treated with anticoagulant - patients treated with oral retinoids: isotretinoin, alitretinoin, acitretin - patients treated with vitamin a patients treated with systemic antibiotics for the duration of treatment - patients treated with barbiturates, carbamazepine or phenytoin - patients with treatment that may have an effect on covid-19 infection: chloroquine, hydroxychloroquine, remdesivir, ganciclovir, acyclovir, ribavirin, lopinavir-ritonavir - patients under guardianship or trusteeship or in safeguard of justice |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Nantes University Hospital |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
46 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
France |
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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 |
|
Total sample size
Last imported at : April 21, 2022, 1 a.m. Source : ClinicalTrials.gov |
0 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Percentage of Patients with Clinical Respiratory Aggravation;Percentage of patients requiring ventilatory assistance;Percentage of patients hospitalized |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 418, "treatment_name": "Doxycycline", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |