COVID-19Phase 2NCT05381519
A Study to Evaluate the Efficacy and Safety of DXP604 in Patients With Mild to Moderate COVID-19
A Phase 2 study testing DXP604 in people with COVID-19, run by Wuhan Institute of Biological Products Co., Ltd.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19
- What is being tested?
- DXP604
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 25Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
Read more
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
- Conditions
- COVID-19
- Being tested
- DXP604
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXP604Biological
1800mg，IVgtt
| Study group | Role | What they receive |
|---|---|---|
| DXP604 | Experimental | 1800mg，IVgtt Receives: Biological: DXP604 |
| placebo | Placebo comparator | IVgtt Receives: Biological: DXP604 |
What is being measured
The primary outcome is the main question the study is designed to answer.
viral load of SARS-CoV-2 virus in nasopharyngeal swab samples
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
Measured: from baseline (2 h ± 30 min before dosing) to day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study startMay 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Institute of Biological Products Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381519
- Sponsor's protocol ID
- DXP604-201
- Status last verified
- May 2022
- First submitted
- 16 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05381519
- Acronym / sponsor ID
- DXP604-201
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wuhan Institute of Biological Products Co., LtdIndustry (pharma, biotech, devices)
- Study start
- May 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DXP604 | Experimental | Biological: DXP6041800mg，IVgtt |
| placebo | Placebo comparator | Biological: DXP604IVgtt |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (25 listed)
- Severe COVID-19 patients who meet any of the following:
- Critically ill patients with COVID-19 who meet any of the following:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DXP6041800mg，IVgtt | Biological | DXP604, placebo |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DXP604 in people with COVID-19, run by Wuhan Institute of Biological Products Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jin ronghua, Bachelor (010-84322000, bjdtyyll@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
viral load of SARS-CoV-2 virus in nasopharyngeal swab samples (time frame: from baseline (2 h ± 30 min before dosing) to day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.