Coronavirus Clinical Trial
— DC-COVID-19Official title:
Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19
The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - The participants were diagnosed as COVID-19 pneumonia, according to the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4 or update version) made by National Health Commission of the People's Republic of China. - Written the informed consent Exclusion Criteria: - Hypersensitivity to darunavir, cobicistat, or any excipients - Patients with severe liver injury (Child-Pugh Class C) - Concomitant medications that are highly dependent on CYP3A clearance, and the elevated plasma concentrations are associated with serious or life-threatening events. - Subjects were considered to be unable to complete the study, or not suitable for the study by researchers Exit criteria: - Subjects asked to withdraw the study - Subject will benefit if withdraw according to researchers' suggestions |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Public Health Clinical Center | Shanghai | Shanghai |
China | Shanghai Public Health Clinical Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Public Health Clinical Center |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 | 7 days after randomization | ||
Secondary | The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 | 3 days after randomization | ||
Secondary | The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5 | 5 days after randomization | ||
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 14 days after randomization | ||
Secondary | The critical illness rate of subjects at weeks 2 | The diagnosis of critical illness case was based on the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4) made by National Health Commission of the People's Republic of China. | 14 days after randomization | |
Secondary | The mortality rate of subjects at weeks 2 | 14 days after randomization |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05065827 -
Lung Ultrasound Findings in Patients With COVID-19 in a UK ED
|
||
Recruiting |
NCT05359770 -
Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19
|
N/A | |
Completed |
NCT04515147 -
A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
|
Phase 2 | |
Not yet recruiting |
NCT06025812 -
Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells)
|
N/A | |
Recruiting |
NCT05289115 -
Protocol for Assistance to Patients With Long Covid-19 Undergoing Treatment With HD-tDCS
|
N/A | |
Completed |
NCT04779138 -
Increasing Vaccine Uptake in Underresourced Public Housing Areas
|
N/A | |
Completed |
NCT04953078 -
A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19
|
Phase 1 | |
Not yet recruiting |
NCT05868239 -
Impact of Aerosol Box Use During Cardiopulmonary Arrest: A Multicenter Study
|
N/A | |
Completed |
NCT04690413 -
NOWDx Test for the Detection of Antibodies to COVID-19
|
N/A | |
Completed |
NCT04818164 -
Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome
|
||
Terminated |
NCT04530448 -
Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization
|
Phase 4 | |
Completed |
NCT04572399 -
UVA Light Device to Treat COVID-19
|
N/A | |
Recruiting |
NCT04610567 -
Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease With Methotrexate Associated to LDL Like Nanoparticles (Nano-COVID19)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04772170 -
Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
|
||
Recruiting |
NCT04581954 -
Inflammatory Signal Inhibitors for COVID-19 (MATIS)
|
Phase 1/Phase 2 | |
Completed |
NCT04405934 -
COG-UK Project Hospital-Onset COVID-19 Infections Study
|
N/A | |
Enrolling by invitation |
NCT04484025 -
SPI-1005 Treatment in Moderate COVID-19 Patients
|
Phase 2 | |
Completed |
NCT05572840 -
Wear Your Mask, Wash Your Hands, Don't Get COVID-19
|
N/A | |
Withdrawn |
NCT04838847 -
A Study to Evaluate the Immunogenicity and Safety of the SARS-CoV-2 mRNA Vaccine CVnCoV in Elderly Adults Compared to Younger Adults for COVID-19
|
Phase 3 | |
Terminated |
NCT04371978 -
Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19
|
Phase 3 |