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

NCT05651815 | Unknown DMC

• 1 other identifier: IRB2022075
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Corona Virus Disease 2019; Randomized Control Trial; Adjuvant Therapy; Graphene Photothermal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hospital stay

  through study completion, an average of 15 days

• Negative test rate within 7 days

  7 days

• Mild to moderate rate within 14 days

  14 days

Other Outcomes (1)

• Lymphocytes variation

  through study completion, an average of 15 days

Study Arms (2)

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

EXPERIMENTAL

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

Conventional therapy group (control group)

NO INTERVENTION

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

Interventions

Graphene spectrum light wave therapy room DEVICE

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

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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℃.

Sponsors & Collaborators

• Southeast University, China: lead
• Hohhot First Hospital: collaborator

Study Sites (1)

Hohhot First Hospital

Hohhot, Inner Mongolia, 010031, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Songqiao Liu, PhD.

  Southeast University

  STUDY CHAIR

Central Study Contacts

Songqiao Liu, PhD.

CONTACT

086-02583262550; liusongqiao@ymail.com

Junjing Zhang

CONTACT

086-04175281618; zhang.jj@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zhongda Hospital

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 15, 2022
• Study Start: November 22, 2022
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)