Graphene Photothermal Adjuvant Therapy for Mild Corona Virus Disease 2019: A Prospective Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Graphene Photothermal Adjuvant Therapy for Mild Corona Virus Disease 2019: A Prospective Randomized Controlled Trial

Conditions
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COVID-19

Intervention / Treatment
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* Device: Graphene spectrum light wave therapy room


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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℃.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Graphene adjuvant therapy combined with conventional therapy group (treatment group)<br>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. | Device: Graphene spectrum light wave therapy room<br>* Undergo 30-min of graphene adjuvant therapy every day for 7 d.<br>|
| No Intervention: Conventional therapy group (control group)<br>Conventional therapy group (control group)：Patients will only receive the conventional treatment for COVID-19. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time from positive at baseline to negative SARS-CoV-2 nucleic acid test | 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. | through study completion, an average of 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Time to hospitalization for COVID-19 | through study completion, an average of 15 days | 
| Negative test rate within 7 days | the rate of negative test of patients | 7 days | 
| Mild to moderate rate within 14 days | Mild to moderate rate within 14 days | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corona Virus Disease 2019, Randomized Control Trial, Adjuvant Therapy, Graphene Photothermal