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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05651815
Recruitment Status : Recruiting
First Posted : December 15, 2022
Last Update Posted : December 15, 2022
Sponsor:
Collaborator:
Hohhot First Hospital
Information provided by (Responsible Party):
Songqiao Liu, Southeast University, China

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 22, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hospital stay [ Time Frame: through study completion, an average of 15 days ]
    Time to hospitalization for COVID-19

  2. Negative test rate within 7 days [ Time Frame: 7 days ]
    the rate of negative test of patients

  3. Mild to moderate rate within 14 days [ Time Frame: 14 days ]
    Mild to moderate rate within 14 days


Other Outcome Measures:
  1. Lymphocytes variation [ Time Frame: through study completion, an average of 15 days ]
    Lymphocytes count



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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℃.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05651815


Contacts
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Contact: Songqiao Liu, PhD. 086-02583262550 liusongqiao@ymail.com
Contact: Junjing Zhang 086-04175281618 zhang.jj@vip.163.com

Locations
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China, Inner Mongolia
Hohhot First Hospital Recruiting
Hohhot, Inner Mongolia, China, 010031
Contact: Junjing Zhang    086-04175281618    zhang.jj@vip.163.com   
Sponsors and Collaborators
Southeast University, China
Hohhot First Hospital
Investigators
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Study Chair: Songqiao Liu, PhD. Southeast University
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Responsible Party: Songqiao Liu, Zhongda Hospital, Southeast University, China
ClinicalTrials.gov Identifier: NCT05651815    
Other Study ID Numbers: IRB2022075
First Posted: December 15, 2022    Key Record Dates
Last Update Posted: December 15, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We did not seek or receive approval for this data sharing from our Institutional Review Board .

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Songqiao Liu, Southeast University, China:
Corona Virus Disease 2019
Randomized Control Trial
Adjuvant Therapy
Graphene Photothermal
Additional relevant MeSH terms:
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Virus Diseases
Coronavirus Infections
COVID-19
Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases