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

Southeast University, China

Status: Enrolling

Conditions: COVID-19

Treatments: Device: Graphene spectrum light wave therapy room

Study type: Interventional

Funder types: Other

Identifiers

NCT05651815

IRB2022075

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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℃.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Graphene adjuvant therapy combined with conventional therapy group (treatment group)

Experimental group

Description:

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.

Treatment:

Device: Graphene spectrum light wave therapy room

Conventional therapy group (control group)

No Intervention group

Description:

Conventional therapy group (control group)：Patients will only receive the conventional treatment for COVID-19.