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

Sponsor

Southeast University, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT05651815

Collaborator

Hohhot First Hospital (Other)

270

Enrollment

Location

Arms

7.2

Anticipated Duration (Months)

37.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Device: Graphene spectrum light wave therapy room	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

270 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 22, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Graphene adjuvant therapy combined with conventional therapy group (treatment group) 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 Undergo 30-min of graphene adjuvant therapy every day for 7 d.
No Intervention: Conventional therapy group (control group) Conventional therapy group (control group)：Patients will only receive the conventional treatment for COVID-19.

Arm

Intervention/Treatment

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

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

Undergo 30-min of graphene adjuvant therapy every day for 7 d.

No Intervention: Conventional therapy group (control group)

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

Outcome Measures

Primary Outcome Measures

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

Hospital stay [through study completion, an average of 15 days]
Time to hospitalization for COVID-19
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

Other Outcome Measures

Lymphocytes variation [through study completion, an average of 15 days]
Lymphocytes count

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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℃.