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

December 7, 2022 updated by: Songqiao Liu, Southeast University, China
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010031
        • Recruiting
        • Hohhot First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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)
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
Time Frame: 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.
through study completion, an average of 10 days

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Collaborators

Hohhot First Hospital

Investigators

  • Study Chair: Songqiao Liu, PhD., Southeast university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Graphene spectrum light wave therapy room

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe