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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Device: Graphene spectrum light wave therapy room

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 Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Songqiao Liu, PhD.; Phone Number: 086-02583262550; Email: liusongqiao@ymail.com
• Study Contact Backup: Name: Junjing Zhang; Phone Number: 086-04175281618; Email: zhang.jj@vip.163.com

Study Locations

• China
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 010031
      • Recruiting
      • Hohhot First Hospital
      • Contact: Junjing Zhang; Phone Number: 086-04175281618; Email: zhang.jj@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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℃.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymphocytes variation	Lymphocytes count	through study completion, an average of 15 days

Collaborators and Investigators

• Sponsor: Southeast University, China
• Collaborators: Hohhot First Hospital
• Investigators: Study Chair: Songqiao Liu, PhD., Southeast university

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Estimate): December 15, 2022

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Randomized Control Trial; Adjuvant Therapy; Corona Virus Disease 2019; Graphene Photothermal
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Virus Diseases
• Other Study ID Numbers: IRB2022075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We did not seek or receive approval for this data sharing from our Institutional Review Board .

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No