- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05381519
A Study to Evaluate the Efficacy and Safety of DXP604 in Patients With Mild to Moderate COVID-19
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of DXP604 in Patients With Mild to Moderate COVID-19
A phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of DXP604 in patients with mild to moderate COVID-19.
By determination of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) virus in nasopharyngeal swab samples by reverse transcription quantitative polymerase chain reaction (RT-qPCR) from baseline (2 h ± 30 min before dosing) to Viral load changes on day 8,to evaluate the efficacy of DXP604 monotherapy in patients with mild to moderate coronavirus disease 2019 (COVID-19).
It was assumed that the difference in viral load change of SARS-CoV-2 virus from baseline (2 h ± 30 min before administration) to day 8 in nasopharyngeal swab samples by RT-qPCR between the experimental drug group and the placebo group was -1.00 log10 copies/mL.The null and alternative hypotheses comparing the experimental drug group with the placebo group are set as follows:
H0:µ1 = µ2 H1:µ1 ≠ µ2
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: jin ronghua, Bachelor
- Phone Number: 010-84322000
- Email: bjdtyyll@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The age of the subjects when signing the ICF is 18 to 70 years old (including 18 and 70 years old), male or female;
- Possess venous access conditions, allowing drug administration and blood sample collection according to the research protocol;
- SARS-CoV-2 positive in any laboratory-confirmed sample within 96 hours before screening;
- According to the National Health Commission of the People's Republic of China (NHC) "New Coronary Virus Pneumonia Diagnosis and Treatment Program", the ninth revised version of the trial was clinically classified as mild/ordinary patients;
- There is at least one factor that may lead to a high risk of severe/critical COVID-19: ① age > 60 years; ② cardiovascular and cerebrovascular diseases (including hypertension), chronic lung diseases (chronic obstructive pulmonary disease, chronic obstructive pulmonary disease, Moderate to severe asthma), diabetes, chronic liver, kidney disease, tumor and other basic diseases; ③ immunodeficiency (such as AIDS patients, long-term use of corticosteroids or other immunosuppressive drugs lead to immunosuppression); ④ obesity (physical constitution) index ≥ 30); ⑤ Heavy smokers.
- Symptoms of COVID-19 ≤ 5 days before randomization; such as fever, cough, shortness of breath, sore throat, diarrhea, vomiting, and dysgeusia;
- Agree to collect nasopharyngeal swabs, saliva and venous blood;
- The subjects can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the ICF.
Exclusion Criteria:
Severe COVID-19 patients who meet any of the following:
- Shortness of breath, respiratory rate ≥ 30 times/min;
- In resting state, blood oxygen saturation (SpO2) ≤ 93% when inhaling air;
- Arterial blood oxygen partial pressure PaO2/inhaled oxygen concentration (FiO2)≤300mmHg (1mmHg=0.133kPa); Note: For areas with high altitude (over 1000 meters above sea level), the following formula should be used to correct PaO2/FiO2: PaO2/FiO2×[760/air pressure (mmHg)];
- The clinical symptoms are progressively worsened, and lung imaging shows that the lesion progresses significantly within 24 to 48 hours by >50%;
Critically ill patients with COVID-19 who meet any of the following:
- Respiratory failure occurs and requires mechanical ventilation;
- Shock occurs;
- Complicated with other organ failure requires ICU monitoring and treatment;
- Those who are known to be allergic to the test drug and its components;
- Hemodynamic instability within 24 hours before treatment allocation requires the use of vasopressors;
- Suspected or confirmed serious, active bacterial, fungal, viral or other infections (except for COVID-19) that the investigator believes may pose a risk when taking interventions;
- Any comorbidities requiring surgery within 7 days prior to screening, or comorbidities deemed life-threatening within 29 days prior to screening;
- Any serious concomitant systemic disease, condition or disorder that the investigator believes should be prevented from participating in this study;
- Patients with positive anti-SARS-CoV-2 immunoglobulin G (IgG) and IgG>10;
- Patients with malignant tumors who are undergoing chemotherapy and radiotherapy before and after surgery;
- Those who have received SARS-CoV-2 specific immunoglobulin (including monoclonal antibody) therapy;
- Those who have completed the vaccination against COVID-19 within 1 month;
- Those who have a history of receiving convalescent COVID-19 plasma treatment;
- Received any study treatment for COVID-19 within 30 days prior to administration, including but not limited to antiviral drugs, corticosteroids, interleukin-1 inhibitors, interleukin-6 inhibitors, and intravenous immunoglobulin;
- Participated in clinical trials of other drugs within 3 months before screening;
- Those who are dizzy with acupuncture and blood;
- Within 4 months after signing the ICF to the end of the trial, those who have a childbearing plan or who do not agree to take effective non-drug contraceptive measures during this period;
- Pregnant and lactating women;
- Other factors considered by the investigator to be inappropriate for entry into this trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DXP604
1800mg,IVgtt
|
1800mg,IVgtt
|
Placebo Comparator: placebo
IVgtt
|
1800mg,IVgtt
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
viral load of SARS-CoV-2 virus in nasopharyngeal swab samples
Time Frame: from baseline (2 h ± 30 min before dosing) to day 8
|
determination of changes in viral load of SARS-CoV-2 virus in nasopharyngeal swab samples from baseline (2 h ± 30 min before dosing) to day 8
|
from baseline (2 h ± 30 min before dosing) to day 8
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DXP604-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
Clinical Trials on DXP604
-
BeiGeneCompleted