Graphene Photothermal Adjuvant Therapy for Mild Corona Virus Disease 2019: A Prospective Randomized Controlled Trial
- Conditions
- COVID-19
- Interventions
- Device: Graphene spectrum light wave therapy room
- Registration Number
- NCT05651815
- Lead Sponsor
- Southeast University, China
- Brief Summary
This is a future-proof and randomized controlled clinical study on the clinical efficacy of graphene photothermal adjuvant therapy in Corona Virus Disease 2019(COVID-19) patients with mild symptoms. The objective is to examine the effect of graphene photothermal adjuvant therapy on the time line for such Corona Virus Disease 2019 patients to achieve a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid test result, and their duration of disease. Patients who meet study criteria will be randomized into the Grapheme adjuvant therapy combined with conventional therapy group (treatment group) and the conventional therapy only group (control group). Contrasted to the control groups, the treatment groups will undergo 30-min of graphene adjuvant therapy every day for 7 d.
- Detailed Description
Following enrollment, patients will be randomized into treatment or control groups. All groups will receive the same conventional therapy.
In addition, treatment groups will undergo Graphene adjuvant therapy 30 minutes per day for 7 d.
Upon completion of the treatment protocol, specific study endpoints will be compared between the treatment and control groups.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 270
- Meet the diagnostic criteria for mild COVID-19.
- Patients aged 18-60 years (inclusive).
- No later than 48 h after testing positive and the onset of clinical symptoms
- Sign informed consent form.
- Severe or critically patients with COVID-19.
- Resting heart rate over 120 beats per minute.
- Coronary heart disease patients with acute cardiac insufficiency.
- Acute exacerbation of chronic obstructive pulmonary disease（COPD）.
- Uncontrolled hypertension [resting systolic blood pressure(SBP) more than 180 mmHg and diastolic blood pressure(DBP) more than 90 mmHg]; uncontrolled diabetes(Random Plasma Glucose, RPG>16.7mmol/L, HbA1C>7.0%)
- Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases.
- Pregnant or menstruating woman.
- Known or suspected history of active tuberculosis or extrapulmonary tuberculosis, patients with brucellosis, pneumonia-related illness from other causes
- COVID-19 patients for the second or more times
- Those who cannot cooperate due to various reasons
- Body temperature: more than 38℃.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Graphene adjuvant therapy combined with conventional therapy group (treatment group) Graphene spectrum light wave therapy room Graphene adjuvant therapy combined with conventional therapy group (treatment group)：Contrasted to the control groups, the treatment groups will undergo 30-min of graphene adjuvant therapy every day for 7 d.
- Primary Outcome Measures
Name Time Method The time from positive at baseline to negative SARS-CoV-2 nucleic acid test through study completion, an average of 10 days The time for grouped patients to receive a negative SARS-CoV-2 nucleic acid test result, including both ORF gene Ct value≥35 and N gene Ct value≥35.
- Secondary Outcome Measures
Name Time Method Negative test rate within 7 days 7 days the rate of negative test of patients
Mild to moderate rate within 14 days 14 days Mild to moderate rate within 14 days
Hospital stay through study completion, an average of 15 days Time to hospitalization for COVID-19
Trial Locations
- Locations (1)
Hohhot First Hospital
🇨🇳Hohhot, Inner Mongolia, China