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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Graphene spectrum light wave therapy room
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Corona Virus Disease 2019, Randomized Control Trial, Adjuvant Therapy, Graphene Photothermal

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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℃.

Sites / Locations

  • Hohhot First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

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

Conventional therapy group (control group)

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hospital stay
Time to hospitalization for COVID-19
Negative test rate within 7 days
the rate of negative test of patients
Mild to moderate rate within 14 days
Mild to moderate rate within 14 days

Full Information

First Posted
November 28, 2022
Last Updated
December 7, 2022
Sponsor
Southeast University, China
Collaborators
Hohhot First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05651815
Brief Title
Graphene Photothermal Adjuvant Therapy for Mild Corona Virus Disease 2019: A Prospective Randomized Controlled Trial
Official Title
Graphene Photothermal Adjuvant Therapy for Mild Corona Virus Disease 2019: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
Collaborators
Hohhot First Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Corona Virus Disease 2019, Randomized Control Trial, Adjuvant Therapy, Graphene Photothermal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Graphene adjuvant therapy combined with conventional therapy group (treatment group)
Arm Type
Experimental
Arm 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.
Arm Title
Conventional therapy group (control group)
Arm Type
No Intervention
Arm Description
Conventional therapy group (control group)：Patients will only receive the conventional treatment for COVID-19.
Intervention Type
Device
Intervention Name(s)
Graphene spectrum light wave therapy room
Intervention Description
Undergo 30-min of graphene adjuvant therapy every day for 7 d.
Primary Outcome Measure Information:
Title
The time from positive at baseline to negative SARS-CoV-2 nucleic acid test
Description
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.
Time Frame
through study completion, an average of 10 days
Secondary Outcome Measure Information:
Title
Hospital stay
Description
Time to hospitalization for COVID-19
Time Frame
through study completion, an average of 15 days
Title
Negative test rate within 7 days
Description
the rate of negative test of patients
Time Frame
7 days
Title
Mild to moderate rate within 14 days
Description
Mild to moderate rate within 14 days
Time Frame
14 days
Other Pre-specified Outcome Measures:
Title
Lymphocytes variation
Description
Lymphocytes count
Time Frame
through study completion, an average of 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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℃.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songqiao Liu, PhD.
Phone
086-02583262550
Email
liusongqiao@ymail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Junjing Zhang
Phone
086-04175281618
Email
zhang.jj@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Songqiao Liu, PhD.
Organizational Affiliation
Southeast University
Official's Role
Study Chair
Facility Information:
Facility Name
Hohhot First Hospital
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junjing Zhang
Phone
086-04175281618
Email
zhang.jj@vip.163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We did not seek or receive approval for this data sharing from our Institutional Review Board .

Learn more about this trial

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

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