Photobiomodulation Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease

NCT ID: NCT04391712

Last Updated: 2020-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2020-07-16

Brief Summary

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The aim of this study is to evaluate the effectiveness of MLS laser therapy as a treatment for pulmonary complications due to COVID-19 infection.

Detailed Description

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Participants will be randomized into treatment vs. control group. Both groups will receive regular inpatient medical treatment. Participants in the experimental arm will receive laser treatments once daily for 4 days. Treatments will be delivered to the patients in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz. Standard nursing protocols would be used to identify participant's pulmonary status throughout treatment.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will utilize a randomized parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Participants will receive MLS laser treatment along with regular inpatient medical care.

Group Type EXPERIMENTAL

MLS Laser

Intervention Type DEVICE

Treatments will be delivered to the participants days 1-4, in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz.

Control Group

Participants will receive regular inpatient medical care.

Group Type ACTIVE_COMPARATOR

Regular Inpatient Medical Care

Intervention Type OTHER

Regular inpatient medical care

Interventions

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MLS Laser

Treatments will be delivered to the participants days 1-4, in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz.

Intervention Type DEVICE

Regular Inpatient Medical Care

Regular inpatient medical care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* COVID-19 positive
* Pulmonary compromise requiring oxygen support of approximately 2-6 liters
* Able to self prone, or support in self-sitting position

Exclusion Criteria

* Ventilator management
* Patients with autoimmune disorders or inflammatory conditions not related to COVID-19
* Pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lowell General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Scott Sigman, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott Sigman, MD

Role: PRINCIPAL_INVESTIGATOR

Lowell General Hospital

Locations

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Lowell General Hospital

Lowell, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2020.01

Identifier Type: -

Identifier Source: org_study_id

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